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(b)(4).Procode is krd/hcg.(b)(4).Concomitant medical products: guidewire (chikai14, asahi intecc), optimo guiding catheter (tokai medical product), sl-10 microcatheter (stryker), dcb2 detachment control box.[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm for an arteriovenous malformation (avm), the pre-treatment histocryl material flowed into the oa feeder and the coils (stryker, target xl 360 soft 3 x 9 and 5 x 15) were placed in to the lesion.The micrusframe 10 6mm x 26cm coil (mfr100626 / s11575) was inserted but the coil did not come out of the sheath.The delivery wire was exposed at the middle portion of the sheath.The micrusframe coil was replaced with another micrusframe (micrusframe 18 8 x 30).Histocryl was introduced and the procedure was successfully completed without further issue or delay.No excessive force was used at any time during the procedure.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The product was returned for investigation.Investigation summary: the device was returned without any packaging or labeling.The embolic coil protrudes from the skive of the translucent introducer sheath and is tangled around the device positioning unit (dpu).The device was gently untangled.The distal end of the embolic coil is located in the translucent introducer sheath.Approximately 25 cm of dpu core wire protrudes from the skive of the translucent introducer sheath just distal to the resheathing tool.The introducer lock has been pulled through the resheathing tool, and the ball tip of the translucent introducer sheath is in the notch of the resheathing tool.There is a bend in the dpu core wire approximately 91 cm from the proximal end.There is a kink in the protruded section of the dpu core wire, approximately 116 cm from the proximal end.There is some residue blocking the distal end of the green introducer.The ball tip is intact.There is a kink in the sheathed section of the embolic coil.The embolic coil is not damaged where it passes out of the skive of the translucent introducer sheath.The exposed embolic coil is kinked and stretched.The articulating joint is anchored in the skive of the translucent introducer sheath at the proximal end of the exposed embolic coil.The proximal end of the embolic coil is kinked and stretched.The resistance heating (rh) coil is partly visible through the skive of the translucent introducer sheath, but its condition cannot be determined.The introducer lock is found on the distal side of the resheathing tool.The ball tip of the translucent introducer sheath has been pulled to the distal end of the notch.The v-notch of the resheathing tool is fractured.Advancement cannot be tested because the embolic coil protrudes from the skive of the translucent introducer sheath.A review of manufacturing documentation associated with this lot (s11575) 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.Device history lot : a review of manufacturing documentation associated with this lot (s11575) 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 that the embolic coil is impeded in the introducer is confirmed.The embolic coil is protruding from the skive of the translucent introducer sheath and cannot be advanced or retracted.The complaint that the prescore ruptured is confirmed.The embolic coil and dpu core wire both protrude through the skive of the translucent introducer sheath.It is likely that the resheathing tool was advanced over the embolic coil while unsheathing the device.The ifu (lcn 208535-001 rev.C) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.Kinks and stretching observed in the exposed portion of the embolic coil are most likely a result of passing through the resheathing tool.The kink observed in the sheathed section of the embolic coil may have been caused during unsheathing when the resheathing tool passed over the embolic coil, or it may be the result of improperly unlocking the device.The v-notch of the resheathing tool is fractured.The damage to the resheathing tool indicates that the device was not properly unlocked.The ifu instructs the user to unlock the device by gently pulling the clear tab of the introducer sheath out and away from the re-sheathing tool at a 45-degree angle.Pulling the tab straight out (in parallel to the dpu) will result in damage to the resheathing tool and may cause damage to the embolic coil.In addition, 100% of devices are inspected for damage to the embolic coil at final assembly per 103002467 rev.13.Thus, it is unlikely that the kink observed in the sheathed portion of the embolic coil was present when the device left the manufacturing facility.The introducer lock has passed through the resheathing tool.This most likely occurred after the reported event, as the user attempted to resheath the device.Application of excessive force as the resheathing tool is pulled back can cause the introducer lock to pass through the resheathing tool.The introducer lock is an intentional deformation of the translucent introducer sheath that cannot re-form around the dpu core wire.Pulling the introducer lock through the resheathing tool will result in protrusion of the dpu core wire.The reported issues that the embolic coil did not come out of the sheath introducer (impeded in the introducer) and of the prescore rupture where the delivery wire was exposed were confirmed with the returned device during the product investigation.The advancement and retraction of the embolic coil could not be achieved due the embolic coil and the delivery wire both protruding through the introducer sheath.This is likely due to the resheathing tool being advanced over the embolic coil during the process of unsheathing the device.The instruction for use (ifu) specific instruction to instruct the user to unsheathe unsheath a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.Failure to follow the instruction can risk damage to the embolic coil.The kink and stretched condition observed on the embolic coil were most likely due to being passed through the resheathing tool.There was also damage to the v-notch of the resheathing tool, which indicates that the device was most likely not properly unlocked.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the micrusframe 10 6mm x 26cm coil left the manufacturing facility with the damages observed on the embolic coil.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.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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The healthcare professional reported that during the coil embolization procedure of an aneurysm for an arteriovenous malformation (avm), the pre-treatment histoacryl material flowed into the oa feeder and the coils (stryker, target xl 360 soft 3 x 9 and 5 x 15) were placed in to the lesion.The micrusframe 10 6mm x 26cm coil (mfr100626 / s11575) was inserted but the coil did not come out of the sheath.The delivery wire was exposed at the middle portion of the sheath.The micrusframe coil was replaced with another micrusframe (micrusframe 18 8 x 30).Histocryl was introduced and the procedure was successfully completed without further issue or delay.No excessive force was used at any time during the procedure.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The product was returned for investigation.
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