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 investigation of the returned coil system found the implant broken and to be attached to the pusher.Burn marks were found on the pusher's heater coil indicating the device was activated using a detachment controller.Replication testing was performed using a compatible lab provided introducer sheath and microcatheter resulting in heavy resistance/friction, which is consistent with the damage found on the device.The unit passed continuity and resistance testing, and the implant was successfully detached during testing.The stretching and fracture of the implant is consistent with the device experiencing tensile (i.E.Retraction) forces that exceeded the strength of the coil's wire.The microcatheter used in the procedure was not evaluated as a part of this evaluation; therefore, the investigation could not determine if it had caused or contributed to the reported complaint.The instructions for use (ifu) identifies difficult coil detachment and premature coil detachment as potentials complications associated with use of the device.
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