PRESSUREWIRE¿

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

REPORTEDLY, THE PRESSUREWIRE X - WIRELESS DEVICE WAS DIFFICULT TO REMOVE FROM THE HOOP DURING PREPARATION. AFTER REMOVAL, THE DEVICE WAS ADVANCED TOWARDS THE LESION, HOWEVER, THE TIP OF THE DEVICE BECAME STUCK IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND RESISTANCE WAS FELT WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT'S ANATOMY. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTIES REMOVING THE GUIDEWIRE WERE NOT ABLE TO BE CONFIRMED; HOWEVER, THE PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED INDICATION OF A POTENTIAL QUALITY ISSUE. BASED ON THE REPORTED INFORMATION AND THE REVIEWS PERFORMED, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES REMOVING APPEAR TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. A POTENTIAL PRODUCT QUALITY ISSUE WAS IDENTIFIED RELATED TO DIFFICULTY REMOVING THE GUIDEWIRE FROM THE DISPENSER COIL, WHICH THEN CAUSED THE REPORTED DIFFICULTY TO REMOVE FROM THE ANATOMY; THEREFORE, A CAPA HAS BEEN INITIATED TO ADDRESS THE ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.