PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE PROXIMAL MALE CONNECTOR AREA AND PROXIMAL TUBE WERE BENT AND KINKED THROUGHOUT, AND THE PROXIMAL TUBE WAS SEPARATED EXPOSING THE COREWIRE. THE REPORTED STRETCHED DISTAL TIP COIL 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, A DEFINITIVE CAUSE FOR THE REPORTED STRETCHED DISTAL TIP COIL COULD NOT BE DETERMINED. THE DEVICE WAS RETURNED WITH KINKS, BENDS, AND A SEPARATION TO THE GUIDEWIRE BODY; HOWEVER, THERE WAS NO STRETCHING TO THE GUIDEWIRE AS IT WAS REPORTED. IN THIS CASE, IT IS POSSIBLE THAT THE OBSERVED GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING TECHNIQUES EMPLOYED WHICH WAS INTERPRETED AS STRETCHING BY THE USER; 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 WAS REMOVED OUT OF THE PACKAGE. IT WAS NOTED THAT THE (THREADS HAD STRIPPED) COILS WERE STRETCHED. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS REVEALED THERE WAS A SEPARATION OF THE PROXIMAL TUBE EXPOSING THE COREWIRE FOR APPROXIMATELY 67.5 CM. NO ADDITIONAL INFORMATION WAS PROVIDED.