BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE

    MDR report key: 3871360 · Received May 21, 2014

    Report

    Report Number
    3871360
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING CARDIAC CATHETERIZATION. THE RIGHT RADIAL ARTERY WAS CANNULATED, THEN UPON ADVANCING THE WIRE AND THE IKARI CATHETER, THE CARDIOLOGIST NOTED THAT THERE WAS A LOOP IN THE LEFT RADIAL ARTERY. HE NEGOTIATED THE LOOP WITH A BALANCE MIDDLE WEIGHT (BMW)WIRE DISTALLY. HE TRIED TO ADVANCE THE GUIDING CATHETER OVER A 2.5 MM BALLOON, BUT DUE TO THE TORTUOSITY OF THE LOOP HE WAS NOT ABLE TO ADVANCE THE EQUIPMENT. HE RETRIEVED THE BALLOON AND WIRE, BUT NOTICED THAT THE WIRE WAS DISCONNECTED IN THE MIDDLE AT THE TRANSITION SITE AND ONLY THE DISTAL END OF THE WIRE CAME OUT. THE OTHER END WAS STUCK INTO THE BRACHIAL ARTEY. HE ADVANCED A WHISPER WIRE TO THE LEVEL OF THE BRACHIAL ARTERY, AGAIN THROUGH THE LOOP, HOPING TO SNARE THE DISCONNECTED WIRE, BUT AGAIN THE WHISPER WIRE BROKE AT THE LEVEL OF THE BRACHIAL ARTERY. HE WAS ABLE TO SNARE THE WHISPER WIRE WITH A SNARE. HE THEN HAD TO CANNULATE THE FEMORAL ARTERY, ADVANCE A SNARE, AND CAPTURE THE BMW WIRE. BOTH BROKEN WIRES WERE SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303687 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * 4032571
    303688 HI-TORQUE WHISPER MS GUIDEWIRE WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * 3121471

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NAMIC 3 PORT MANIFOLD, TERUMO MEDICAL CORP.6 FR.| GLIDESHEATH SLENDER AND 6 FR. HEARTRAIL III| COOK MEDICAL 18 G. ENTRY NEEDLE, BOSTON SCIENTIFIC