BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIGHT WIRE II

    MDR report key: 1244444 · Received November 26, 2008

    Report

    Report Number
    2939520-2008-00031
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    January 25, 2008
    Report Date
    November 28, 2008
    Manufacturer
    VOLCANO CORP
    Product Code
    DQX
    PMA / PMN Number
    K021219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL INSPECTION OF THE DEVICE WAS PERFORMED BY A TEAM CONSISTING OF MANUFACTURING ENGINEERING, R&D, AND QA. THE PHYSICAL EXAMINATION OF THE BRIGHTWIRE WAS UNREMARKABLE, EXCEPT FOR A SHARP BEND JUST AT THE PROXIMAL END OF THE SCREW TIP GLUE JOINT OF ABOUT 30 DEGREES. A FEW SLIGHT KINKS IN THE DISTAL COIL SECTION WERE NOTED, BUT NO SIGNIFICANT COIL STRETCH OR OTHER DAMAGE WAS NOTED. NO SIGNIFICANT DAMAGE OR DISTORTION OF THE PROXIMAL COIL OR THE HYPOTUBE WAS FOUND. THE PRESSURE SENSOR WAS FUNCTIONAL. A MORE DETAILED MICROSCOPIC EXAMINATION OF THE BRIGHTWIRE HOUSING DID NOT REVEAL ANY MARKS OR DAMAGE TO THE BRIGHTWIRE. THERE WERE NO OBSERVED PROCESS OR WORKMANSHIP DEFECTS NOTED ON THE WIRE. THERE WAS NO OBSERVED EVIDENCE TO CONCLUDE THAT THE WIRE WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    BRIGHTWIRE WAS INTRODUCED IN LAD - WIRE GET STUCK IN PROXIMAL SECTION OF IMPLANTED STENT (BETWEEN STENT STRUT & VESSEL WALL) RESULTING IN A DISSECTION. A STENT WAS IMPLANTED TO CORRECT DISSECTION. PATIENT DISCHARGED FROM HOSPITAL 1 DAY AFTER PROCEDURE WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHT WIRE II FUNCTIONAL MEASUREMENT WIRE DQX VOLCANO CORP 6600 039-01050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention