THE PRODUCT WAS NOT RETURNED TO ABBOTT FOR ANALYSIS. RETURN OF THE GUIDE WIRE MAY HAVE FURTHER AIDED THE ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO ADVANCE OR DIFFICULTY TO REMOVE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS AND/OR COMPLAINT REPORTED FROM THIS LOT. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO PREPARATION OF THE WIRE WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE POSTERIOR TIBIAL ARTERY. DURING ADVANCEMENT THE COMMAND GUIDE WIRE BECAME STUCK INSIDE A NON-ABBOTT CROSSING CATHETER. THE COMMAND GUIDE WIRE COULD NOT BE REMOVED FROM THE CROSSING CATHETER, SO BOTH DEVICES WERE REMOVED AS A UNIT. THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.