| Model Number MFR182050 |
| Device Problems
Fracture (1260); Difficult to Advance (2920); Premature Separation (4045)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/10/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (l13458) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Unusual resistance and friction during advancement and/or withdrawal and premature detachment necessitating additional intervention are known potential complications associated with the use of embolic coils in endovascular embolization.The micrusframe instructions for use (ifu) cautions that if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system, examine for damage, and replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical and procedural factors, including aneurysm/vessel characteristics, device selection, device interaction, and operator technique, that may have contributed to the reported event rather than the design or manufacture of the device.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of premature detachment.The coil protrusion during attempted removal of the concomitant microcatheter may have been related to the complaint coil becoming entangled/anchored to the competitor coil that was stuck inside the microcatheter.Root cause determination is pending additional investigation and return of the associated devices.Since the alleged device failures necessitated additional intervention (i.E., use of snare) to preclude patient complications, the event meets mdr reporting criteria as a ¿serious injury.¿ if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Event Description
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The healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the splenic artery, after a 20mm x 50cm micrusframe s coil was delivered via the concomitant masters parkway soft microcatheter (asahi-intecc) and successfully implanted as the first coil, a 20mm x 50cm micrusframe 18 coil (mfr182050 / l13458) was the second coil selected for use.It was inserted into the same concomitant masters parkway soft microcatheter, but an intense resistance was encountered when the coil slightly exited the distal end of the microcatheter.The physician attempted to remove the coil, but the coil was unable to be retracted.The physician applied some force, ¿which brought feeling as if the complaint coil got cut.¿ the delivery wire was removed without the embolic coil attached.The embolic coil that remained in the microcatheter was flushed with a syringe; the coil came out of the microcatheter and appeared to be implanted in the target aneurysm.A tornado® embolization coil (cook medical) was used as the third coil.There was a resistance felt inside the microcatheter and the coil failed to advance.The microcatheter was removed, but the complaint coil (second coil) came out of the aneurysm.A snare was used to retrieve the complaint coil from the patient.The microcatheter was replaced and the procedure was completed with a push-able coil.There was no report of any patient adverse event or complication as a result of the event.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 31 march 2021.The product analysis lab reviewed the photos taken and provided by the j&j japan affiliates.[photo analysis]: the photos provided included the concomitant microcatheter and the 20mm x 50cm micrusframe 18 coil.The device positioning unit (dpu) and the introducer sheath were not included / captured in the photos.The coil was observed to be damaged, stretched and broken into two pieces.Due to the condition of the coil in the photos, it could not be determined if the embolic coil had been prematurely detached from the device; the device positioning unit (dpu) was not captured in the photos.There were no other damages nor anomalies observed in the photos.The issues reported in the complaint related to the resistance between the coil and the concomitant microcatheter, the resistance / friction during the attempt to withdraw the coil, and the premature detachment of the coil could not be confirmed based on the photos provided.Further investigation will be performed when the device has been returned and received for evaluation and analysis.A review of manufacturing documentation associated with this lot (l13458) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the modified preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on (b)(6) 2021.The product analysis lab reviewed the modified photos taken and provided by the j&j japan affiliates.[photo analysis]: the additional / modified photos of the complaint device were reviewed.The photos did not provide further or additional information about the possible cause of the reported issue that would impact the original photo assessment of the complaint device.The previous photo assessment is as following: the device positioning unit (dpu) and the introducer sheath were not included / captured in the photos.The coil was observed to be damaged, stretched and broken into two pieces.Due to the condition of the coil in the photos, it could not be determined if the embolic coil had been prematurely detached from the device; the device positioning unit (dpu) was not captured in the photos.There were no other damages nor anomalies observed in the photos.The issues reported in the complaint related to the resistance between the coil and the concomitant microcatheter, the resistance / friction during the attempt to withdraw the coil, and the premature detachment of the coil could not be confirmed based on the photos provided.Further investigation will be performed when the device has been returned and received for evaluation and analysis.A review of manufacturing documentation associated with this lot (l13458) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the splenic artery, after a 20mm x 50cm micrusframe s coil was delivered via the concomitant masters parkway soft microcatheter (asahi-intecc) and successfully implanted as the first coil, a 20mm x 50cm micrusframe 18 coil (mfr182050 / l13458) was the second coil selected for use.It was inserted into the same concomitant masters parkway soft microcatheter, but an intense resistance was encountered when the coil slightly exited the distal end of the microcatheter.The physician attempted to remove the coil, but the coil was unable to be retracted.The physician applied some force, ¿which brought feeling as if the complaint coil got cut.¿ the delivery wire was removed without the embolic coil attached.The embolic coil that remained in the microcatheter was flushed with a syringe; the coil came out of the microcatheter and appeared to be implanted in the target aneurysm.A tornado® embolization coil (cook medical) was used as the third coil.There was a resistance felt inside the microcatheter and the coil failed to advance.The microcatheter was removed, but the complaint coil (second coil) came out of the aneurysm.A snare was used to retrieve the complaint coil from the patient.The microcatheter was replaced and the procedure was completed with a push-able coil.There was no report of any patient adverse event or complication as a result of the event.On 23 april 2021, additional information was received indicating that continuous flush was not maintained through the concomitant masters parkway soft microcatheter.The entire coil was removed by the snare.There was no flow restriction / reduction as a result of the reported event.It was confirmed that there was no allegation of patient injury / adverse event due to the reported event.Anonymized imaging/procedural films are not available for review.[potential root cause analysis]: it is important to note that the inner diameter (id) of all parkway microcatheters is 0.022¿ or larger.The micrusframe and deltafill microcoil 14 and 18 systems are compatible with microcatheters with inner lumen diameters ranging from 0.0165 to 0.021 in (0.419 mm to 0.533 mm).Preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 31 march 2021.The product analysis lab reviewed the photos taken and provided by the j&j japan affiliates.[photo analysis]: the photos provided included the concomitant microcatheter and the 20mm x 50cm micrusframe 18 coil.The device positioning unit (dpu) and the introducer sheath were not included / captured in the photos.The coil was observed to be damaged, stretched and broken into two pieces.Due to the condition of the coil in the photos, it could not be determined if the embolic coil had been prematurely detached from the device; the device positioning unit (dpu) was not captured in the photos.There were no other damages nor anomalies observed in the photos.The issues reported in the complaint related to the resistance between the coil and the concomitant microcatheter, the resistance / friction during the attempt to withdraw the coil, and the premature detachment of the coil could not be confirmed based on the photos provided.Modified preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 06 april 2021.The product analysis lab reviewed the modified photos taken and provided by the j&j japan affiliates.[photo analysis]: the additional / modified photos of the complaint device were reviewed.The photos did not provide further or additional information about the possible cause of the reported issue that would impact the original photo assessment of the complaint device.The previous photo assessment is as following: the device positioning unit (dpu) and the introducer sheath were not included / captured in the photos.The coil was observed to be damaged, stretched and broken into two pieces.Due to the condition of the coil in the photos, it could not be determined if the embolic coil had been prematurely detached from the device; the device positioning unit (dpu) was not captured in the photos.There were no other damages nor anomalies observed in the photos.The issues reported in the complaint related to the resistance between the coil and the concomitant microcatheter, the resistance / friction during the attempt to withdraw the coil, and the premature detachment of the coil could not be confirmed based on the photos provided.The device was received by the product analysis lab on 21 april 2021.The investigational finding is documented below.Investigation summary: the non-sterile 20mm x 50cm micrusframe 18 coil was received contained in a pouch.Visual inspection was performed.The embolic coil was visually inspected and observed to be severely damaged and in stretched condition.The rest of the device component was not returned.Microscopic inspection was performed.The embolic coil was inspected and under manigfication, it was observed that the embolic coil is separated in three parts / sections.The three sections of the embolic coil were severely damaged and stretched.The distal section of the coil that usually remains attached to the resistance heating (rh) coil was not returned for evaluation.As a result, it cannot be determined if the embolic coil was mechanically detached or if the detachment process was initiated as the device positioning unit (dpu) was also not returned.There were residues of dried blood observed near the bead.No other damages nor anomalies were observed.Functional evaluation could not be performed as only the embolic coil was returned.The condition of the embolic coil is severely damaged and stretched.Although the condition of the returned embolic coil precluded functional evaluation, the severe damage observed both during visual inspection and under microscopic manigfication may have been related to the reported issue documented in the complaint when the intense resistance was encountered followed by the force applied by the physician during the attempt to remove the coil ¿which brought feeling as if the complaint coil got cut.¿ a review of manufacturing documentation associated with this lot (l13458) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint documented that during the procedure targeting the aneurysm located at the splenic artery, the complaint coil was the second coil selected for use.It was inserted into the masters parkway soft microcatheter but was met with intense resistance when the coil slightly exited the distal end of the microcatheter.The physician attempted to remove the coil, but the coil was unable to be retracted.The physician applied some force, ¿which brought feeling as if the complaint coil got cut.¿ the delivery wire was removed without the embolic coil attached.The entire coil was removed by the snare.Functional evaluation was not conducted due to the condition of the returned device as well as an incomplete device return.Only the embolic coil was returned.Although functional testing could not be performed, the severely damaged and stretched condition of the embolic coil confirmed the reported issue in the complaint.The coil was reported to have become prematurely detached in the microcatheter was confirmed as only the embolic coil was returned.The exact time the coil became prematurely detached cannot be determined.The embolic coil may have become detached when the physician applied force during the attempt to remove the coil but it could not be retracted.The resistance friction issue encountered during the attempt to retract the coil may be due to the insufficient flush through the microcatheter; it was reported via additional information that continuous flush was not maintained through the concomitant masters parkway soft microcatheter.The residues of dried blood observed during the microscopic inspection is likely due to the insuffificent flush through the microcatheter.Without an adequate and continuous flush maintained through the microcatheter, the embolic coil could encounter resistance during attempt to advance / withdrawal, which could result in the embolic coil becoming damaged / stretched as observed on the returned device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the complaint device left the manufacturing facility with the coil in the observed in severely damaged and stretched condition.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following cautions: ¿ if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Unusual resistance and friction during advancement and/or withdrawal and premature detachment necessitating additional intervention are known potential complications associated with the use of embolic coils in endovascular embolization.The micrusframe instructions for use (ifu) cautions that if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system, examine for damage, and replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical and procedural factors, including aneurysm/vessel characteristics, device selection, device interaction, and operator technique, that may have contributed to the reported event rather than the design or manufacture of the device.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of premature detachment.The coil protrusion during attempted removal of the concomitant microcatheter may have been related to the complaint coil becoming entangled/anchored to the competitor coil that was stuck inside the microcatheter.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the condition observed on the returned coil was related to a manufacturing or design issue, no corrective actions will be taken at this time.Updated sections: g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 23 april 2021.E.1: initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[additional information]: the healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the splenic artery, after a 20mm x 50cm micrusframe s coil was delivered via the concomitant masters parkway soft microcatheter (asahi-intecc) and successfully implanted as the first coil, a 20mm x 50cm micrusframe 18 coil (mfr182050 / l13458) was the second coil selected for use.It was inserted into the same concomitant masters parkway soft microcatheter, but an intense resistance was encountered when the coil slightly exited the distal end of the microcatheter.The physician attempted to remove the coil, but the coil was unable to be retracted.The physician applied some force, ¿which brought feeling as if the complaint coil got cut.¿ the delivery wire was removed without the embolic coil attached.The embolic coil that remained in the microcatheter was flushed with a syringe; the coil came out of the microcatheter and appeared to be implanted in the target aneurysm.A tornado® embolization coil (cook medical) was used as the third coil.There was a resistance felt inside the microcatheter and the coil failed to advance.The microcatheter was removed, but the complaint coil (second coil) came out of the aneurysm.A snare was used to retrieve the complaint coil from the patient.The microcatheter was replaced and the procedure was completed with a push-able coil.There was no report of any patient adverse event or complication as a result of the event.On 23 april 2021, additional information was received indicating that continuous flush was not maintained through the concomitant masters parkway soft microcatheter.The entire coil was removed by the snare.There was no flow restriction / reduction as a result of the reported event.It was confirmed that there was no allegation of patient injury / adverse event due to the reported event.Anonymized imaging/procedural films are not available for review.Unusual resistance and friction during advancement and/or withdrawal and premature detachment necessitating additional intervention are known potential complications associated with the use of embolic coils in endovascular embolization.The micrusframe instructions for use (ifu) cautions that if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system, examine for damage, and replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical and procedural factors including device interaction, insufficient flush, aneurysm/vessel characteristics, device selection, and operator technique that may have contributed to the reported event rather than the design or manufacture of the device.Additional information received indicated that a continuous flush was not maintained through the ancillary microcatheter.This may have caused or contributed to the intensive resistance encountered by the operator as the coil slightly exited the distal tip of the microcatheter.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of premature detachment.The coil protrusion during attempted removal of the concomitant microcatheter may have been related to the complaint coil becoming entangled/anchored to the competitor coil that was stuck inside the microcatheter.Root cause determination is pending evaluation of the associated devices.Since the alleged device failures necessitated additional intervention (i.E., use of snare) to preclude patient complications, the event meets mdr reporting criteria as a ¿serious injury.¿ the manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 21 april 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the potential root cause analysis.[additional information]: the healthcare professional reported that during a coil embolization procedure with the target aneurysm located at the splenic artery, after a 20mm x 50cm micrusframe s coil was delivered via the concomitant masters parkway soft microcatheter (asahi-intecc) and successfully implanted as the first coil, a 20mm x 50cm micrusframe 18 coil (mfr182050 / l13458) was the second coil selected for use.It was inserted into the same concomitant masters parkway soft microcatheter, but an intense resistance was encountered when the coil slightly exited the distal end of the microcatheter.The physician attempted to remove the coil, but the coil was unable to be retracted.The physician applied some force, ¿which brought feeling as if the complaint coil got cut.¿ the delivery wire was removed without the embolic coil attached.The embolic coil that remained in the microcatheter was flushed with a syringe; the coil came out of the microcatheter and appeared to be implanted in the target aneurysm.A tornado® embolization coil (cook medical) was used as the third coil.There was a resistance felt inside the microcatheter and the coil failed to advance.The microcatheter was removed, but the complaint coil (second coil) came out of the aneurysm.A snare was used to retrieve the complaint coil from the patient.The microcatheter was replaced and the procedure was completed with a push-able coil.There was no report of any patient adverse event or complication as a result of the event.On 23 april 2021, additional information was received indicating that continuous flush was not maintained through the concomitant masters parkway soft microcatheter.The entire coil was removed by the snare.There was no flow restriction / reduction as a result of the reported event.It was confirmed that there was no allegation of patient injury / adverse event due to the reported event.Anonymized imaging/procedural films are not available for review.[potential root cause analysis]: it is important to note that the inner diameter (id) of all parkway microcatheters is 0.022¿ or larger.The micrusframe and deltafill microcoil 14 and 18 systems are compatible with microcatheters with inner lumen diameters ranging from 0.0165 to 0.021 in (0.419 mm to 0.533 mm).Updated sections: g.3, g.6.H.2, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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