Investigation of the returned optowire iii confirmed that the guidewire was fractured at 307 mm from its distal end, in the proximal joint of the shaft portion of the device.The proximal fragment displayed a strong kink at the fracture point.Based on the event information provided and inspection of the guidewire, it is estimated that the resistance encountered during the introduction of the guidewire into the guiding catheter caused a significant kink of the guidewire.The subsequence push force led to the fracture of the guidewire at the kink position review of device history record confirmed that the optowire lot was released per specifications.No link was established between the incident and the deviations documented on the optowire lot.The investigation did not identify any new risk.The risks associated with the event are disclosed in the optowire iii instructions for use (ifu): if resistance occurs and the cause of resistance cannot be determined, do not move or torque the optowire.Stop the procedure, determine the cause of resistance under fluoroscopy and take appropriate action.Never advance an optowire against resistance without first determining the reason for the resistance under fluoroscopy.Excessive force against resistance may result in damage to the wire and/or to the vessel.If resistance occurs and the cause of resistance cannot be determined, do not move or torque the optowire.Stop the procedure, determine the cause of resistance under fluoroscopy and take appropriate action.A corrective action request was already put in place by the manufacturer.No additional action intended as a result of the incident.
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