THE SAFARI2 GUIDEWIRE IS EXPECTED TO BE RETURNED FOR EVALUATION BUT HAD NOT BEEN RECEIVED AT THE TIME THIS MEDWATCH REPORT WAS SUBMITTED. THE END USER DID PROVIDE LOT TRACEABILITY FOR THE SAFARI2 GUIDEWIRE USED IN THIS CASE. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DID NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED OR THE PRODUCT IS RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.
D
Patient 1
AS REPORTED BY THE DISTRIBUTOR: EVENT DESCRIPTION: IT WAS REPORTED THAT: THEY TOOK THE SAFARI2 WIRE IN INTO THE LEFT VENTRICLE. THEY WERE ACTUALLY DOING A PROCEDURE CALLED A BASILICA. THIS WAS PART OF A BUNCH OF OTHER WIRES AND APPARENTLY THEY SNARED ACCIDENTALLY THE TIP OF THIS SAFARI2 WIRE AND THEY PULLED IT AND SO IT WAS UNRAVELING. THEY WERE ABLE TO GET IT OUT NO PROBLEM BUT SR JUST WANTED TO CALL IT IN AND MAKE SURE TO REPLACE THE DEVICE AS THEY WERE PRETTY NERVOUS ABOUT IT. THE CASE WAS COMPLETED FINE. THEY SWITCHED IN FOR ANOTHER WIRE (AMPLATZ) AND THAT WORKED FINE. THIS HAPPENED DURING THE PROCEDURE, INSIDE OF THE PATIENT'S BODY. NO COMPLICATIONS.