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

IT WAS REPORTED THAT RESISTANCE WAS FELT WHILE ATTEMPTING TO INSERT THE PRESSUREWIRE X (PWX), DEVICE INTO THE GUIDE CATHETER. UPON REMOVAL FROM THE GUIDE CATHETER, A BREAK WAS NOTED NEAR THE DISTAL TIP OF THE DEVICE. 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 AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE DIFFICULTY ADVANCING WAS UNABLE TO BE CONFIRMED AS IT WAS RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 OBSERVATIONS FROM THE RETURNED ANALYSIS, THE REPORTED RESISTANCE ADVANCING AND TIP DAMAGE WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT THE GUIDING CATHETER WAS BENT OR KINKED CAUSING RESISTANCE DURING ADVANCEMENT AND THE NOTED STRETCHED TIP COILS DURING REMOVAL. ALTHOUGH A BREAK WAS NOT CONFIRMED, THE NOTED STRETCHED TIP COILS WAS LIKELY THE INTENDED DAMAGE BEING REPORTED. 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.