Date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(6).(b)(4).A jagwire guidewire was returned.The returned device was inspected under magnification and showed, the distal tip of the device with a missing portion of about 0.4 cm, the corewire has a little portion fractured.The detached portion returned in a separate container.The ptfe coating was detached exposing corewire.The reported complaint of distal tip detached is confirmed.Based on the condition of the returned device, engineers determined that the problem observed, it is most likely that as part of the device manipulation during procedure an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the peeled section on the distal end.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported event.
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