Block h6 (device codes): imdrf device code a0501 captures the reportable event of core wire broken.Block h10: the returned jagwire was analyzed.Upon visual assessment, it was observed that the jagwire ptfe coating area was peeled and accordioned.In addition, the core wire is separated into two sections.Based on the condition of the returned device, engineers determined that the problem observed, is most likely due to device manipulation during the 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 device coating as well as the core wire to be separated into two sections.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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