PRESSUREWIRE¿

Description of Event or Problem

REPORTEDLY, THE PWX DEVICE WAS CALIBRATED SUCCESSFULLY. HOWEVER, THE PRESSURE SIGNAL WAS UNSTABLE, AND EQUALIZATION COULD NOT BE ACHIEVED. THE TRANSMITTER 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.

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED PRESSURE REGISTRATION FAILURE 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 FAULTY PRESSURE REGISTRATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE DEVICE WAS RETURNED WITH DAMAGE TO THE PRESSURE SENSOR OF THE GUIDEWIRE, WHICH RESULTED IN THE REPORTED AND CONFIRMED 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, AND CONFIRMATION OF THE PRODUCT HISTORY RECORDS CONFIRMED SUCCESSFUL TESTING THROUGHOUT THE MANUFACTURING PROCESS. IN THIS CASE, IT IS LIKELY THAT THE DAMAGE TO THE PRESSURE MEMBRANE OF THE SENSOR CHIP OCCURRED DUE TO THE HANDLING OR CLEANING/WIPING OF THE GUIDEWIRE. 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.