PRESSUREWIRE¿

Description of Event or Problem

IT WAS REPORTED THAT DURING PREPARATION, THE PRESSUREWIRE X, CABLED DEVICE HAD NO SIGNAL AND CALIBRATION WAS UNSUCCESSFUL. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND ANOTHER PRESSUREWIRE X, CABLED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE DISTAL TUBE WAS KINKED 3.4 CENTIMETERS PROXIMAL TO THE DISTAL TIP. THE DISTAL TUBE WAS TORN AT THE NOTED KINK, EXPOSING THE MICROCABLES.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION PROBLEM WAS NOT ABLE 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, THE INVESTIGATION DETERMINED THAT THE REPORTED COMMUNICATION PROBLEM APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE CATHETER WAS RETURNED KINKED AND BENT IN MULTIPLE LOCATIONS, WHICH CAUSED DAMAGE TO THE INTERNAL COMPONENTS OF THE DEVICE, A TEAR TO THE DISTAL TUBE, AND THE REPORTED COMMUNICATION PROBLEM. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING TECHNIQUES EMPLOYED. 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.