Investigation conclusion: the investigation of the returned coil system found the pusher heater coil stretched, broken and entangled at the middle section, the yellow lead wire broken, and the implant not attached to the pusher with indications of activation observed on the pusher heater coil; however, the pusher's monofilament showed a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.As the lead wire was returned broken, this investigation could not test or assess the continuity or resistance of the pusher to determine if a condition existed that would have caused or contributed to the alleged non-detachment issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
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