The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The pusher and implant were returned for analysis.The introducer, dispenser hoop, and microcatheter were not returned.Inspection of the pusher found two sections of lead wire separation.Both sections were at the proximal end and measured 11" and 8" respectively.Aside from the lead wire separation, the pusher was found to be in good condition and without damage.The resistance of the pusher was found to be within specification at 40.7 ohms, indicating no damage to the lead wire/solder joints.The implant was found to still be attached to the pusher.No issues were observed at the markerband/heater coil interface.The implant, however, was broken in two pieces.The filament and filar itself were broken.The implant also contained numerous kinks, bends, and stretched locations.Stretching was noted at the break location.Based on the investigation findings and available information, the reported complaint is confirmed; the implant was found to be broken in two pieces as noted in the complaint.The root cause of the break is unknown.The issue is not related to a manufacturing defect.Though the source of the damage on the implant is unknown, the damage is consistent with an implant that was under forces that exceed its specification.The microcatheter and introducer are considered integral components in the root cause analysis and were not returned.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
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It was reported that during embolization of an aneurysm of the left middle cerebral artery, an embolization coil encountered friction during advancement in the microcatheter.During removal of the device from the microcatheter, the implant coil stretched and broke.The device was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.
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