THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. RETURN OF THE GUIDE WIRE MAY HAVE FURTHER AIDED THE ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE REVIEW OF SIMILAR INCIDENT(S) THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO PREPARATION OF THE WIRE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO REMOVE APPEARS TO BE RELATE TO OPERATION CIRCUMSTANCES. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT DURING ADVANCEMENT, THE GUIDE WIRE BECAME DAMAGED WITH THE TOTALLY OCCLUDED ANATOMY CAUSING RESISTANCE AND THE DIFFICULTY TO REMOVE DURING RETRACTION OF THE LASER CATHETER. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL HT COMMAND ES GUIDE WIRE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE TIBIOPERONEAL TRUNK, PERONEAL ARTERY, AND SUPERFICIAL FEMORAL ARTERY. A HT COMMAND ES GUIDE WIRE WAS ADVANCED AND AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED OVER THE GUIDE WIRE. AN ATTEMPT TO REMOVE THE IVUS CATHETER WAS MADE; HOWEVER, RESISTANCE WITH THE GUIDE WIRE WAS FELT. BOTH WERE REMOVED AS A UNIT. A NEW HT COMMAND GUIDE WIRE WAS ADVANCED, AND AN UNSPECIFIED LASER CATHETER WAS ADVANCED OVER THE GUIDE WIRE. AN ATTEMPT TO REMOVE THE LASER CATHETER WAS MADE; HOWEVER, RESISTANCE WITH THE GUIDE WIRE WAS FELT, BUT THE LASER CATHETER WAS ABLE TO BE REMOVED. THE GUIDE WIRE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.