BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMEWIRE

    MDR report key: 1530893 · Received November 16, 2009

    Report

    Report Number
    2939520-2009-00032
    Event Type
    Other
    Date Received
    November 16, 2009
    Date of Event
    October 22, 2009
    Report Date
    October 26, 2009
    Manufacturer
    VOLCANO CORP
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, VISUAL INSPECTION SHOWED THAT THE WIRE WAS RECEIVED IN TWO PIECES. IT WAS RETURNED IN A PLASTIC BIOHAZARD BAG WITHOUT THE PROTECTIVE COIL. AS INDICATED IN THE COMPLAINT DESCRIPTION, THE WIRE WAS CUT INTO TWO PIECES. THE WIRE WAS CUT AT 37.5 CM FROM THE PROXIMAL END (CONNECTOR) OF THE WIRE. MULTIPLE KINKS WERE OBSERVED ON THE PROXIMAL AND DISTAL END OF THE WIRE. THE WIRE WAS MICROSCOPICALLY EXAMINED AND ALL COMPONENTS WERE INTACT AND PRESENT. THE PRESSURE SENSOR WAS INSPECTED AND YELLOW BROWN RUSTY RESIDUE WAS OBSERVED IN THE SENSOR HOUSING. SINCE THE DEVICE WAS CUT INTO TWO PIECES, THE FUNCTIONAL TESTING OF THE DEVICE COULD NOT BE PERFORMED. THEREFORE, WE WERE UNABLE TO DUPLICATE THE ORIGINAL COMPLAINT OF 107 ERROR MESSAGE. BASED ON THE COMPLAINT DESCRIPTION, THE WIRE BECAME BENT WHEN PHYSICIAN WAS TRYING TO LOAD THE BALLOON CATHETER AND THEN WIRE WAS CUT BY THE PHYSICIAN. ALTHOUGH THERE WAS NO PT IMPACT DUE TO THIS INCIDENT, THERE IS A POTENTIAL FOR INJURY SHOULD THIS HAPPEN AGAIN. THIS REPORT IS BEING SENT AS A NOTIFICATION. (B)(4).

    Description of Event or Problem · 1

    FFR OF PLB 0.39 RESTING. PULLED WIRE BACK TO ASSESS MID RCA LESION. GOT NO SIGNAL (WIRE PRESS) (ERROR 107) EVEN THOUGH WIRE WAS REATTACHED SEVERAL TIMES. HAD TO PULL AN IVUS CATHETER THEN STENTED MID RCA. WHEN ATTEMPTING TO LOAD NC BALLOON, WIRE BENT AND WAS CUT BY DR. THEN NC BALLOON LOADED ON CUT PRIMEWIRE. IT RUPTURED THE BALLOON. WE THEN HAD TO BUDDY A BMW, PULL THE PRIMEWIRE AND USE A SECOND NC BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORP 7900 118 02573

    Patients

    Seq Age Sex Outcome Treatment
    1