PRESSUREWIRE¿

Description of Event or Problem

REPORTEDLY, THE PWX DEVICE WAS DIFFICULT TO REMOVE FROM THE PLASTIC HOOP, DURING PREPARATION. DURING THE PROCEDURE AND WHILE RESHAPING THE TIP, THE DEVICE WAS FOUND TO BE BENT. 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. RETURNED GOODS LAB INVESTIGATION, NOTED THE PRESSUREWIRE X - WIRELESS DEVICE'S COREWIRE WAS BROKEN APPROXIMATELY 1 CENTIMETER (CM) DISTAL TO THE SENSOR JACKET.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY TO REMOVE THE GUIDEWIRE FROM THE PACKAGING WAS NOT ABLE TO BE CONFIRMED DURING TESTING; HOWEVER, THE REPORTED BEND/KINK WAS ABLE TO BE VISUALLY CONFIRMED. ALTHOUGH THE REPORTED DIFFICULTY TO REMOVE THE GUIDEWIRE FROM THE PACKAGING WAS NOT ABLE TO BE CONFIRMED DURING RETURNED DEVICE TESTING, BASED ON THE INFORMATION RECEIVED IT WAS DETERMINED THAT THE REPORTED DIFFICULTY TO REMOVE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE, WHICH HAD RESULTED IN THE REPORTED GUIDEWIRE BENDS/KINKS. AN EXCEPTION INVESTIGATION WAS OPENED TO FURTHER EVALUATE THE DIFFICULTY TO REMOVE THE GUIDEWIRE FROM THE PACKAGING COIL ISSUE. THE STRETCHED DISTAL TIP COIL RESULTING IN A BROKEN COREWIRE IS CONSISTENT WITH BEING DAMAGED DURING USE (OVER-SHAPING OF TIP OR EXCESS FORCE APPLIED DURING REMOVAL), AS WELL AS AN EFFECT FROM THE REPORTED DIFFICULTY TO REMOVE THE GUIDEWIRE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.