BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTWIRE II PRESSURE GUIDE WIRE

    MDR report key: 1624993 · Received February 19, 2010

    Report

    Report Number
    2939520-2010-00008
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    October 20, 2009
    Report Date
    January 23, 2010
    Manufacturer
    VOLCANO CORP
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DOCUMENTATION FOR THIS LOT WAS REVIEWED AND TO DATE, ONE SIMILAR COMPLAINT HAS BEEN FILED AGAINST IT FOR INABILITY TO NORMALIZE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED FAILURE MODE. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. FUNCTIONAL TESTING INDICATES THE DEVICE FUNCTIONED AS INTENDED, PASSING THE SIGNAL, ZERO, AND DRIFT TESTS. VISUAL EVALUATION OF THE DEVICE DETERMINED THE DOME FROM THE DISTAL TIP WAS SEPARATED AND MISSING FROM THE DEVICE. PARTS OF THE MISSING DOME WERE VISIBLE IN THE SCREW TIP "WELL" INDICATING THE DOME WAS ADDED DURING MANUFACTURING. THE DOME WAS ALSO PRESENT DURING THE FINAL DEVICE INSPECTION. THE DOME DAMAGE IS NOT RELATED TO THE REPORTED COMPLAINT AS THE DOME HAS NO ELECTRICAL FUNCTIONALITY AND DOES NOT AFFECT THE SIGNAL. THE DOME FROM THE DISTAL TIP IS A 0.5MMX0.5MM ROUNDED DROP OF UVEX EPOXY MATERIAL INTENDED TO ENHANCE SMOOTH TRACKING AND REDUCE RESISTANCE DURING ADVANCEMENT OF THE WIRE DURING USE. THE USER DID NOT NOTE ANY WIRE HANDLING OR "FEEL" ISSUES, SUCH AS STEERABILITY. A MISSING DOME COULD CONTRIBUTE TO DECREASED WIRE HANDLING PERFORMANCE. THE DOME CAN BE DAMAGED OR WEAKENED BY EXPOSURE TO OXIDIZING AGENTS SUCH AS BLEACH OR PEROXIDES WHICH ARE COMMONLY USED IN HOSPITALS FOR DISINFECTION OF DEVICES AFTER USE. HOWEVER, THE METHOD OF DECONTAMINATION OF THE DEVICE PRIOR TO RETURN SHIPMENT TO VOLCANO IS UNKNOWN. ALTHOUGH, IT IS POSSIBLE THE DOME SEPARATED WHILE INSIDE THE PATIENT, SINCE NO ADVERSE EVENTS WERE REPORTED, THIS SCENARIO IS UNLIKELY. AS IT IS NOT POSSIBLE TO DETERMINE WHEN THE DOME SEPARATED, THIS EVENT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE BRIGHTWIRE II PRESSURE GUIDE WIRE GAVE A FAULTY MEASUREMENT EVEN WHEN THE WIRE WAS RE-ZEROED. AFTER CHANGING TO ANOTHER WIRE, THE MEASUREMENTS WERE CORRECT. BASED ON THE ANGIO RESULTS (PATIENT HAD 3 VESSEL DISEASE) THE PATIENT WAS REFERRED FOR CABG. THIS OCCURRENCE IS NOT A REPORTABLE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. PRIOR TO DEVICE DECONTAMINATION, THE DEVICE WAS VISUALLY INSPECTED AND THE 0.5MM X 0.5MM UVEX DOME WAS OBSERVED TO BE SEPARATED AND MISSING FROM THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTWIRE II PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORP 7603 038 01059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other