PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SIGNAL CALIBRATION FAILURE WAS NOT CONFIRMED. THE PRESSUREWIRE WAS ABLE TO BE CONNECTED AND CALIBRATED. 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, A DEFINITIVE CAUSE FOR THE REPORTED SIGNAL CALIBRATION FAILURE COULD NOT BE DETERMINED AS FUNCTIONAL TESTING CONFIRMED THAT THE DEVICE WAS ABLE TO CONNECT AND CALIBRATE WITH A QUANTIEN SYSTEM. IT MAY BE POSSIBLE THAT AN INSUFFICIENT ELECTRICAL CONTACT OCCURRED BETWEEN THE PRESSUREWIRE AND PWX TRANSMITTER, OR A SYSTEM ISSUE OCCURRED; HOWEVER, THIS COULD NOT BE CONFIRMED. THE NOTED BENDS, KINKS, AND BREAK TO THE DISTAL TUBE WERE NOT REPORTED AND LIKELY OCCURRED DUE TO POST-PROCEDURE HANDLING. THE DAMAGE DO NOT APPEAR TO BE RELATED TO REPORTED SIGNAL CALIBRATION FAILURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B3, B6: DATES ESTIMATED.

Description of Event or Problem

IT WAS REPORTED THE PRESSUREWIRE 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 ANALYSIS OF THE PRESSUREWIRE X REVEALED THERE WAS A BREAK IN THE DISTAL TUBE AT THE KINKED SEGMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.