PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAULTY PRESSURE REGISTRATION WAS UNABLE TO BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED FAULTY PRESSURE REGISTRATION COULD NOT BE DETERMINED. FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE DEVICE DUE TO THE CONDITION OF THE RETURNED GUIDEWIRE (DISTAL TUBE BENT, KNOTTED AND TORN), WHICH WAS DETERMINED TO HAVE BEEN CAUSED DURING POST USE HANDLING OR MANIPULATION. IN THIS CASE, IT IS POSSIBLE THAT THE GUIDEWIRE¿S INTERNAL COMPONENTS HAD BECOME DAMAGED WHEN ADVANCING TO THE EQUALIZATION POINT, WHICH RESULTED IN THE REPORTED FAULTY PRESSURE REGISTRATION; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE CALIBRATED SUCCESSFULLY. THE DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE PD PRESSURE WAS TOO HIGH AND EQUALIZATION WAS UNSUCCESSFUL. 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. RETURNED DEVICE ANALYSIS FOUND THE DISTAL TUBE WAS RETURNED BENT INTO A KNOT 17CM FROM THE DISTAL TIP. THE DISTAL TUBE MATERIAL WAS TORN AT THE NOTED KNOT EXPOSING THE CORE WIRE.