THE SAFARI2 GUIDEWIRE IS EXPECTED TO BE RETURNED FOR FAILURE ANALYSIS BUT WAS NOT RECEIVED AT THE TIME THIS REPORT WAS FILED. LOT TRACEABILITY WAS NOT PROVIDED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THAT DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT CLINICAL AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT AS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED OR PRODUCT IS RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
D
Patient 1
AS REPORTED BY THE DISTRIBUTOR, PATIENT WAS UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT. EVENT DESCRIPTION: IT WAS REPORTED THAT: RECAPTURE OF SECOND VALVE, WIRE WAS STUCK DUE TO OVERSEATED NOSECONE. VALVE RECAPTURED FINE, OVERSEATING WAS CORRECTED, 2ND LE AND SAFARI2 WERE REMOVED TOGETHER BECAUSE WIRE WAS STUCK. REGAINED ACCESS WITH ANOTHER SAFARI2 WIRE. NO PATIENT COMPLICATIONS.