PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. 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 GUIDEWIRE AND SENSOR CHIP DAMAGE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE DEVICE WAS RETURNED WITH KINKS, BENDS, AND DAMAGE TO THE SENSOR CHIP¿S PRESSURE MEMBRANE, WHICH RESULTED IN THE OBSERVED PRESSURE REGISTRATION ISSUE. THE PRESSURE SENSITIVITY OF THE GUIDEWIRE IS TESTED DURING THE MANUFACTURING PROCESS AND PRIOR TO RELEASE TO DEVICE FUNCTIONALITY UPON EXPECTED USE. 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. B3: ESTIMATED DATE.

Description of Event or Problem

THE PWX DEVICE WAS USED DURING THE PROCEDURE, HOWEVER, AN UNKNOWN ERROR OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION, FURTHER INSPECTION REVEALED THE PRESSURE SENSOR PAD IN THE SENSOR CHIP ASSEMBLY WAS CUT/TORN DIAGONALLY ACROSS THE PAD, RESULTING IN FAULTY PRESSURE REGISTRATION.