A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED GUIDE WIRE; HOWEVER, THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED. POSSIBLE FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY TO REMOVE THE GUIDE WIRE FROM THE DELIVERY DEVICE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, GUIDE WIRE DAMAGES, DAMAGE ON THE SHAFT OF THE CATHETER, OUTER DIAMETER OF THE GUIDE WIRE, INNER DIAMETER OF THE GUIDE WIRE LUMEN OR PROCEDURAL CONTAMINATES. DESIGN AND MANUFACTURING CONTROLS HAVE BEEN ESTABLISHED TO MITIGATE POSSIBLE CAUSES. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO REMOVE. BASED ON THE REPORTED INFORMATION IT IS POSSIBLE THAT THE TECHNIQUE USED TO REMOVE THE NON-ABBOTT IVUS CATHETER, CAUSED THE REPORTED RESISTANCE TO BE FELT WITH THE GUIDE WIRE; HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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.