It was reported that the membrane of the fogarty corkscrew catheter was torn and the wire was exposed during use.After replacing the catheter with a different lot number, the catheter could be used without any problem.Patient demographics were requested but unavailable.The devices were discarded at the hospital due to infection.There were no patient complications reported.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.However, an investigation was initiated to assess for any manufacturing related processes which could be correlated to the lot number.Per the device history record review, the device met all specifications upon distribution.Since a failure mode could not be confirmed, further investigation could not be performed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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