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 device was returned to the manufacturer.Only the pusher was returned for analysis.The implant, microcatheter, packaging, and introducer were not returned.The implant and microcatheter were not returned, preventing complete analysis of the reported complaint.The pusher was found to be bent in multiple locations throughout the hypotube.It cannot be determined if the damage was the result of handling during the procedure or the result of returned shipment activities.The distal end of the pusher was also found to be offset and kinked in multiple locations near the platinum coil marker and the attachment locations.Again, it cannot be determined if the damage was the result of handling during the procedure or the result of returned shipment activities.The heater coil was found to be in good condition and without damage.The pusher was found to register green lights and have a resistance measurement within spec.The monofilament was extracted to determine the tensile break profile.The monofilament profile was found to represent a mushroom shape, historically indicating thermal detachment was enacted.Based on the investigation findings and available information, the reported complaint is confirmed.The pusher was returned without the implant attached.The reported complaint states that the detachment occurred within the microcatheter.The microcatheter and implant are considered critical to the root cause analysis.The root cause of the detachment cannot be identified based on the supplied information.Though it cannot be confirmed, the profile of the monofilament is typically the result of a correctly detached implant via a v-grip.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
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