PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED PRESSURE SIGNAL ISSUE WAS 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 PRESSURE SIGNAL DRIFT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE DEVICE WAS RETURNED WITH KINKS AND BENDS, WHICH CAUSED DAMAGE TO THE INTERNAL COMPONENTS OF THE GUIDEWIRE (SHORT CIRCUITS) AND RESULTED IN THE REPORTED AND CONFIRMED PRESSURE SIGNAL ISSUE. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING TECHNIQUES EMPLOYED. THE OBSERVED DAMAGE (BREAK) TO THE GUIDEWIRE'S PRESSURE SENSOR MEMBRANE IS ALSO CONSISTENT WITH BEING DAMAGED DURING OR AFTER USE; HOWEVER, BASED ON THE OBSERVED SHORT CIRCUIT WAS DETERMINED TO BE THE ROOT CAUSE FOR THE REPORTED PRESSURE SIGNAL DRIFT AND THE BREAK TO THE SENSOR MEMBRANE WAS LIKELY CAUSED DURING POST-USE HANDLING/CLEANING FOR DEVICE RETURN. 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

REPORTEDLY, THE PWX DEVICE WAS CALIBRATED AND EQUALIZATION WERE SUCCESSFUL. HOWEVER, THE PRESSURE VALUES DISPLAYED WERE FOUND TO BE HIGHER AND INACCURATE (THE PRESSURE WAS 120/60, IT SHOWED 180/12). THE TRANSMITTER LIGHT WAS GREEN. 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. DURING PRODUCT RETURN INVESTIGATION, A BREAK WAS NOTED IN THE PRESSURE SENSOR MEMBRANE IN THE SENSOR CHIP ASSEMBLY.