BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY

    MDR report key: 2992912 · Received February 28, 2013

    Report

    Report Number
    3006010712-2013-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH HISTORY REVIEW WAS CARRIED OUT WHICH DEMONSTRATED THAT THE GUIDEWIRE WAS MANUFACTURED TO SPECIFICATION. DEVICE EVAL ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    OCCLUSION OF ALL CALF VESSELS DISTALLY DUE TO HEAVILY CALCIFIED VESSELS. RECANALIZATION OF A 3 CM DISTAL OCCLUSION OF ANTERIOR TIBIAL WAS INTENDED. THE WIRE WAS GUIDED BY A 2 MM STERLING (BOSTON) BALLOON CATHETER. A DRILLING MOVEMENT WITH THE WIRE, THE TIP ALLOWED ENTERING THE OCCLUSION FOR 1.5 CM. WHEN THE SUBINTIMAL PASSAGE WAS NOTED, WIRE WITHDRAWAL WAS INTENDED. WHILE PULLING WITHOUT FORCE, THE TIP OF THE WIRE STAYED WITHIN THE CALCIFIED WALL OF THE VESSEL. REMOVAL OF THE WIRE TIP WAS NOT INTENDED. INTERVENTION WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87299 VICTORY GUIDEWIRE DQX BRIVANT, LTD. 901023-23 10148510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other