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| Model Number |
606-151FX |
| Medical Device Problem Codes |
Crack (1135); Physical Resistance/Sticking (4012)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
07/08/2021
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Manufacturers ref.No: (b)(4).The initial reporter phone: (b)(6).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 photo of the concomitant prowler 14 microcatheter was provided on (b)(6) 2021.The product analysis lab reviewed the photo.[photo analysis]: based on the photo, it can be determined that the 150cm x 50cm prowler 14 microcatheter has a break in the integrity of the shaft wall where it can be seen that the 5mm x 15cm deltafill 10 coil protrudes from the area where the break is observed.Due to the distance in which the photo was taken, it cannot be determined if the coil has some damage on it, when the device returns a microscopic evaluation will be carried out.No other damages could be noted on the picture.The issue captured in the complaint related to the condition and appearance of the prowler 14 microcatheter after it was removed from the patient and was checked by the physician where a hole was noted in the catheter body was confirmed based on the photo provided which showed a break in the integrity of the device shaft.Further investigation will be performed once the device returns for analysis to address the reported issues documented in the complaint related to the resistance encountered when the coil was introduced into the microcatheter and the obstructed issue encountered by the 5mm x 15cm deltafill 10 coil.A review of manufacturing documentation associated with this lot (30289569) 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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00319 and 3008114965-2021-00320.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 or Problem Description
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The healthcare professional reported that during an aneurysm embolization procedure targeting a giant basilar artery aneurysm, after the physician had already successfully placed seven (7) different coils using the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569), while trying to finalize coiling using the 9mm x 25cm deltafill 10 coil (dlf100925 / 30395326), there was resistance encountered during the advancement attempt.The physician removed the coil and made another attempt to advance the coil the smaller coil, a 5mm x 15cm deltafill 10 (dlf100515 / 30452192).The same resistance was encountered and it was reported that the coil became stuck in the microcatheter and the physician could not remove the coil.He decided to remove the coil/microcatheter system out of the patient; the physician checked the device on the table and noted that the prowler 14 microcatheter has a hole in it; there was a visible kink on the prowler 14 microcatheter.Continuous flush had been maintained through the microcatheter.It was reported that the 9mm x 25cm deltafill 10 coil that was removed was not stretched, it was still attached to the delivery system.There was no blood flow reduction / restriction as a result of the reported issue.The physician decided to finish the procedure without attempting to introduce additional coils; the procedure was considered complete with the implantation of the 7 coils.The patient is reported as stable.There was no report of any patient adverse event or complication.
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the complaint device was received on 26-oct-2021, however, it was mistakenly identified as one of the two complaint coils.On 27-oct-2021, the product analysis lab discovered that the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569) was received with one of the two complaint coils stuck inside the lumen.The purpose of this mdr submission is also to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an aneurysm embolization procedure targeting a giant basilar artery aneurysm, after the physician had already successfully placed seven (7) different coils using the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569), while trying to finalize coiling using the 9mm x 25cm deltafill 10 coil (dlf100925 / 30395326), there was resistance encountered during the advancement attempt.The physician removed the coil and made another attempt to advance the coil the smaller coil, a 5mm x 15cm deltafill 10 (dlf100515 / 30452192).The same resistance was encountered and it was reported that the coil became stuck in the microcatheter and the physician could not remove the coil.He decided to remove the coil/microcatheter system out of the patient; the physician checked the device on the table and noted that the prowler 14 microcatheter has a hole in it; there was a visible kink on the prowler 14 microcatheter.Continuous flush had been maintained through the microcatheter.It was reported that the 9mm x 25cm deltafill 10 coil that was removed was not stretched, it was still attached to the delivery system.There was no blood flow reduction / restriction as a result of the reported issue.The physician decided to finish the procedure without attempting to introduce additional coils; the procedure was considered complete with the implantation of the 7 coils.The patient is reported as stable.There was no report of any patient adverse event or complication.A photo of the concomitant prowler 14 microcatheter was provided on 16 july 2021.The product analysis lab reviewed the photo.[photo analysis]: based on the photo, it can be determined that the 150cm x 50cm prowler 14 microcatheter has a break in the integrity of the shaft wall where it can be seen that the 5mm x 15cm deltafill 10 coil protrudes from the area where the break is observed.Due to the distance in which the photo was taken, it cannot be determined if the coil has some damage on it, when the device returns a microscopic evaluation will be carried out.No other damages could be noted on the picture.The issue captured in the complaint related to the condition and appearance of the prowler 14 microcatheter after it was removed from the patient and was checked by the physician where a hole was noted in the catheter body was confirmed based on the photo provided which showed a break in the integrity of the device shaft.The complaint device was received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 150cm x 50cm prowler 14 microcatheter was received with the 5mm x 15cm deltafill 10 coil stuck inside its lumen.An attempt was made to remove the coil from the microcatheter, but it could not be removed.Visual inspection was conducted on the microcatheter.The microcatheter was observed cracked and in a twisted condition.The core wire and the embolic coil component of the 5mm x 15cm deltafill 10 coil were observed protruding out of the cracked section of the microcatheter.No other damages nor anomalies were observed during the visual inspection.Dimensional analysis: the outer diameter (od) was measured and observed to be within specification.The inner diameter (id) could not be measured due to the complaint coil stuck inside the lumen.The actual microcatheter od (45 cm from the distal end) was measured to be 0.0315-inch.The maximum specification is 0.032-inch.Functional evaluation was precluded due to the 5mm x 15cm deltafill 10 coil stuck inside the microcatheter lumen.A review of manufacturing documentation associated with this lot (30289569) 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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following recommendation: if strong resistance is met during manipulation, discontinue the procedure, and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.The complaint documented that the 5mm x 15cm deltafill 10 coil was the smaller coil used after the 9mm x 25cm deltafill 10 coil chosen as the final coil during the aneurysm embolization procedure targeting a giant basilar artery aneurysm encountered resistance during the advancement attempt.The 5mm x 15cm deltafill 10 coil encountered the same resistance as the 9mm x 25cm deltafill 10 coil; it was reported that the coil became stuck in the microcatheter and the physician could not remove the coil.He decided to remove the coil/microcatheter system out of the patient; the physician checked the device on the table and noted that the prowler 14 microcatheter has a hole in it; there was a visible kink on the prowler 14 microcatheter.Continuous flush had been maintained through the microcatheter.The complaint microcatheter was received with the 5mm x 15cm deltafill 10 coil stuck inside as reported in the complaint.The attempt made to remove the coil from the microcatheter was unsuccessful.Visual inspection noted that the microcatheter has a cracked section and is in a twisted condition, which may be the result of the attempt to remove the coil from the microcatheter, though this cannot be conclusively determined.The core wire and the embolic coil component of the 5mm x 15cm deltafill 10 coil were observed protruding out of the cracked section.This is consistent with the observation made based on the photo included in the complaint which noted a break in the integrity of the catheter shaft with the embolic coil protruding from this area.Functional analysis was precluded but the reported issue was confirmed based on the visual inspection.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of three (3) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00319, 3008114965-2021-00320 and 3008114965-2021-00540.Corrected sections: section h.3: device evaluated by manufacturer.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, h.10, and h.11.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.Correction: on 26-oct-2021, two products were received in the product analysis lab.One of the two received products was mistakenly identified as one of the two coils documented in the complaint.On 27-oct-2021, the product analysis lab discovered that the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569) was received with one of the two complaint coils stuck inside the lumen.Section h.3: device evaluated by manufacturer? was corrected from 'not returned to manufacturer' to 'yes.'.
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the initial medwatch report (3008114965-2021-00320).On 26-oct-2021, it was confirmed that the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569) is no longer available for return; the product was discarded.[conclusion]: the healthcare professional reported that during an aneurysm embolization procedure targeting a giant basilar artery aneurysm, after the physician had already successfully placed seven (7) different coils using the 150cm x 50cm prowler 14 microcatheter (606151fx / 30289569), while trying to finalize coiling using the 9mm x 25cm deltafill 10 coil (dlf100925 / 30395326), there was resistance encountered during the advancement attempt.The physician removed the coil and made another attempt to advance the coil the smaller coil, a 5mm x 15cm deltafill 10 (dlf100515 / 30452192).The same resistance was encountered and it was reported that the coil became stuck in the microcatheter and the physician could not remove the coil.He decided to remove the coil/microcatheter system out of the patient; the physician checked the device on the table and noted that the prowler 14 microcatheter has a hole in it; there was a visible kink on the prowler 14 microcatheter.Continuous flush had been maintained through the microcatheter.It was reported that the 9mm x 25cm deltafill 10 coil that was removed was not stretched, it was still attached to the delivery system.There was no blood flow reduction / restriction as a result of the reported issue.The physician decided to finish the procedure without attempting to introduce additional coils; the procedure was considered complete with the implantation of the 7 coils.The patient is reported as stable.There was no report of any patient adverse event or complication.A photo of the concomitant prowler 14 microcatheter was provided on 16 july 2021.The product analysis lab reviewed the photo.[photo analysis]: based on the photo, it can be determined that the 150cm x 50cm prowler 14 microcatheter has a break in the integrity of the shaft wall where it can be seen that the 5mm x 15cm deltafill 10 coil protrudes from the area where the break is observed.Due to the distance in which the photo was taken, it cannot be determined if the coil has some damage on it, when the device returns a microscopic evaluation will be carried out.No other damages could be noted on the picture.The issue captured in the complaint related to the condition and appearance of the prowler 14 microcatheter after it was removed from the patient and was checked by the physician where a hole was noted in the catheter body was confirmed based on the photo provided which showed a break in the integrity of the device shaft.Based on the information received on 26-oct-2021, it was confirmed that the product was discarded and is no longer be available for return.A review of manufacturing documentation associated with this lot (30289569) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided but without the 150cm x 50cm prowler 14 microcatheter available for return, the reported issue associated with the resistance encountered during the advancement attempt through the microcatheter cannot be confirmed through functional evaluation.The reported issue related to a hole noted in the catheter body was confirmed based on the photo provided which showed a break in the integrity of the device shaft.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the issue related to the resistance could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00319 and 3008114965-2021-00320.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.In the initial medwatch report, the value in section h.3 was documented as ¿other¿.In section h.10, it was documented as follows: 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.The product is no longer available for return.Section h.3 device evaluated by manufacturer has been corrected to ¿not returned to manufacturer.¿.
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Search Alerts/Recalls
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