PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SIGNAL CALIBRATION FAILURE WAS 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 REPORTED SIGNAL CALIBRATION FAILURE APPEARS TO BE DUE CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT DAMAGE TO THE INTERNAL COMPONENTS AT THE NOTED BREAK RESULTED IN THE NOTED OPEN CIRCUIT AND REPORTED CALIBRATION FAILURE. IT IS LIKELY THAT THE NOTED KINKS/BENDS AND BREAK TO THE DISTAL TUBE OCCURRED DURING USE AND/OR ADVANCEMENT INTO THE PATIENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B3, B6: DATE ESTIMATED.

Description of Event or Problem

IT WAS REPORTED THE PRESSUREWIRE X - WIRELESS DEVICE COULD NOT CONNECT TO THE SYSTEM. THE WIRE WAS CONTINUOUSLY BLINKING AND FAILED TO ESTABLISH A CONNECTION. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE X DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS OF THE PRESSUREWIRE X REVEALED THERE WAS A BREAK IN THE DISTAL TUBE AT THE KINKED SEGMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.