(b)(4).A jagwire guidewire was returned.Visual analysis of the device revealed evidence of a corewire break in addition, the guidewire was bent at the distal section.Based on the condition of the returned device, engineers determined that the failure modes observed were caused due to handling or manipulation of the device during the procedure or interaction with the scope.Once the wire was bent it could cause difficulty advancing the guidewire.Consequently, when the guidewire was crossing the scope extra force could have been applied leading to the corewire break.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 event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.That no anomalies or deviations related to the event occurred during manufacturing.
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