| Model Number GLX120304 |
| Device Problems
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 11/18/2021 |
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Event Type
malfunction
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Event Description
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The healthcare professional reported that during an emergent coil embolization of a ruptured ophthalmic-internal carotid artery aneurysm of approximately 1.5mm x 4mm in size, the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16436) was used as the first framing coil.However, there was an intense resistance felt from the middle to the end of the coil implantation.Continuous flush was maintained through the microcatheter.It was impossible to wind the last 1cm of the complaint coil.The physician re-sheathed the complaint coil but the coil detached inside the concomitant sl-10® microcatheter (stryker).As a result, the coil and microcatheter were removed together from the patient.The coil was then removed from the microcatheter.The same concomitant microcatheter was used with competitor coils to complete the procedure.There was no report of any patient adverse event or complication.Photos of the complaint device were included in the complaint.
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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, and ethnicity 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.Photos of the complaint device were included in the complaint.The product analysis lab reviewed the photos included in the complaint.The observation is documented below.[photo analysis]: based on the photos included the complaint, it can be noted that the embolic coil component of the 3mm x 4cm galaxy g3 xsft is kinked and has several areas of stretched coil.It could also be observed that the blue fiber was exposed.The embolic coil is observed tangled with the device positioning unit (dpu) and detached from the resistance heating (rh) coil.The distal outer sheath could be observed not in a softened state, indicating that the rh coil had not been heated and the detachment process had not been initiated.This indicates that the coil was mechanically separated from the unit.The embolic coil could be observed with some residues of dried blood on it.No other additional damages could be noted.A review of manufacturing documentation associated with this lot (l16436) 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 reported issue that the embolic coil became detached prematurely inside the concomitant microcatheter was confirmed based on the photos provided; the embolic coil component could be noted detached from the unit.However, the exact time of the premature detachment cannot be conclusive determined as the concomitant microcatheter was not shown in the photos.The issue related to the intense resistance encountered could not be evaluated based on the photos.Based on the manufacturing record evaluation, the reported issue are not related to the manufacturing process.Further investigation will be performed when the device is returned for analysis.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 an emergent coil embolization of a ruptured ophthalmic-internal carotid artery aneurysm of approximately 1.5mm x 4mm in size, the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16436) was used as the first framing coil.However, there was an intense resistance felt from the middle to the end of the coil implantation.Continuous flush was maintained through the microcatheter.It was impossible to wind the last 1cm of the complaint coil.The physician re-sheathed the complaint coil but the coil detached inside the concomitant sl-10® microcatheter (stryker).As a result, the coil and microcatheter were removed together from the patient.The coil was then removed from the microcatheter.The same concomitant microcatheter was used with competitor coils to complete the procedure.There was no report of any patient adverse event or complication.Photos of the complaint device were included in the complaint.
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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, and ethnicity 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.Photos of the complaint device were included in the complaint.The product analysis lab reviewed the photos included in the complaint.The observation is documented below.[photo analysis]: based on the photos included the complaint, it can be noted that the embolic coil component of the 3mm x 4cm galaxy g3 xsft is kinked and has several areas of stretched coil.It could also be observed that the blue fiber was exposed.The embolic coil is observed tangled with the device positioning unit (dpu) and detached from the resistance heating (rh) coil.The distal outer sheath could be observed not in a softened state, indicating that the rh coil had not been heated and the detachment process had not been initiated.This indicates that the coil was mechanically separated from the unit.The embolic coil could be observed with some residues of dried blood on it.No other additional damages could be noted.A review of manufacturing documentation associated with this lot (l16436) 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 reported issue that the embolic coil became detached prematurely inside the concomitant microcatheter was confirmed based on the photos provided; the embolic coil component could be noted detached from the unit.However, the exact time of the premature detachment cannot be conclusive determined as the concomitant microcatheter was not shown in the photos.The issue related to the intense resistance encountered could not be evaluated based on the photos.Based on the manufacturing record evaluation, the reported issue are not related to the manufacturing process.Further investigation will be performed when the device is returned for analysis.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 21-dec-2021.[additional information]: the healthcare professional reported that during an emergent coil embolization of a ruptured ophthalmic-internal carotid artery aneurysm of approximately 1.5mm x 4mm in size, the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16436) was used as the first framing coil.However, there was an intense resistance felt from the middle to the end of the coil implantation.Continuous flush was maintained through the microcatheter.It was impossible to wind the last 1cm of the complaint coil.The physician re-sheathed the complaint coil but the coil detached inside the concomitant sl-10® microcatheter (stryker).As a result, the coil and microcatheter were removed together from the patient.The coil was then removed from the microcatheter.The same concomitant microcatheter was used with competitor coils to complete the procedure.There was no report of any patient adverse event or complication.On 21-dec-2021, additional information was received.The information indicated that there was no clinically significant delay in the procedure due to the reported event.E.1: the initial reporter phone: (b)(6).The initial reporter email address is not available / reported.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 04-jan-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, 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)(6).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an emergent coil embolization of a ruptured ophthalmic-internal carotid artery aneurysm of approximately 1.5mm x 4mm in size, the 3mm x 4cm galaxy g3 xsft coil (glx120304 / l16436) was used as the first framing coil.However, there was an intense resistance felt from the middle to the end of the coil implantation.Continuous flush was maintained through the microcatheter.It was impossible to wind the last 1cm of the complaint coil.The physician re-sheathed the complaint coil but the coil detached inside the concomitant sl-10® microcatheter (stryker).As a result, the coil and microcatheter were removed together from the patient.The coil was then removed from the microcatheter.The same concomitant microcatheter was used with competitor coils to complete the procedure.There was no report of any patient adverse event or complication.On 21-dec-2021, additional information was received.The information indicated that there was no clinically significant delay in the procedure due to the reported event.Photos of the complaint device were included in the complaint.The product analysis lab reviewed the photos included in the complaint.The observation is documented below.[photo analysis]: based on the photos included the complaint, it can be noted that the embolic coil component of the 3mm x 4cm galaxy g3 xsft is kinked and has several areas of stretched coil.It could also be observed that the blue fiber was exposed.The embolic coil is observed tangled with the device positioning unit (dpu) and detached from the resistance heating (rh) coil.The distal outer sheath could be observed not in a softened state, indicating that the rh coil had not been heated and the detachment process had not been initiated.This indicates that the coil was mechanically separated from the unit.The embolic coil could be observed with some residues of dried blood on it.No other additional damages could be noted.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 3mm x 4cm galaxy g3 xsft coil was received contained in a pouch.Visual inspection was performed.The embolic coil component was received separated from the device positioning unit (dpu) / core wire in a separate plastic bag included in the pouch.The photos of the complaint device had the embolic coil detached and tangled with the dpu; the embolic coil component of the returned unit is detached but is not tangled with the dpu as shown in the photos.Microscopic inspection was performed.Under magnification, the embolic coil component is observed to be severely stretched with multiple kinks.Two kinks were observed in the core wire near the marker band of the dpu.The resistance heating (rh) coil was inspected and slight traces of evidence that it had been heated were observed along the clear cover of the rh coil.Additionally, the detachment fiber was observed opened.The rh coil of the complaint device as captured in the photos had no evidence that it had been heated, which indicated that the detachment process had not been initiated.However, under magnification, the distal part of the rh coil appeared wavy showing slight traces that it had been subjected to heat.The detachment fiber was open; this suggest that the detachment cycle was inadvertently initiated which resulted in the premature detachment of the embolic coil.The kinks observed on the core wire and on the embolic coil could be secondary to the resistance rather than a contributing factor.Similarly, the stretched condition noted on the embolic coil could have been caused when the prematurely detached coil was removed from the distal part of the microcatheter.The resistance of the returned device could not be tested due to the condition in which it was returned.The concomitant microcatheter has an inner lumen of 0.0165 inches, which is compatible with the complaint device.However, it is possible that the premature detachment could have caused the difficulty to further advance the embolic coil.Therefore, the reported issue was confirmed.The stretched and kinked condition of observed on the embolic coil component during the microscopic inspection were not originally reported in the complaint.Coil stretching and coil kinking are known potential issues associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.The exact cause for the observed stretched and kinked condition cannot be conclusively determined.The kinks may be secondary to the resistance rather than a contributing factor.The stretched condition may have been caused when the prematurely detached coil was removed from the microcatheter.Based on the manufacturing documentation 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 3mm x 4cm galaxy g3 xsft coil left the manufacturing facility with the in the observed stretched and kinked condition.A review of manufacturing documentation associated with this lot (l16436) 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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following recommendations: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.Updated sections: b.4, 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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Search Alerts/Recalls
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