PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, 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 OPERATIONAL CONTEXT. THE DEVICE WAS RETURNED WITH DAMAGE (BREAK) TO THE SENSOR MEMBRANE OF THE GUIDEWIRE, WHICH RESULTED IN THE REPORTED AND CONFIRMED PRESSURE SIGNAL DRIFT. IN THIS CASE, IT IS LIKELY THAT THE SENSOR CHIP DAMAGE WAS CAUSED BY THE HANDLING TECHNIQUES EMPLOYED DURING DEVICE PREPARATION (WIPING). 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, A DRIFT OCCURRED DURING THE PROCEDURE. THE TRANSMITTER WAS GREEN. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PWX 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 AND AFTER CLEANING, THE SENSOR WAS RE-EXAMINED, REVEALING A BREAK IN THE SENSOR PAD MEMBRANE.