BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI -TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE

    MDR report key: 2993120 · Received February 26, 2013

    Report

    Report Number
    MW5029195
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2012
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT HEART CATH A BMW 0.014 INCH WIRE BECAME LODGED IN THE ANTERIOR TIBIAL ARTERY AND BROKE WHEN REMOVAL WAS ATTEMPTED. THERE WAS A RETAINED FRAGMENT OF WIRE IN THE POPLITEAL AND ANTERIOR TIBIAL ARTERY THAT WAS UNABLE TO BE REMOVED. VASCULAR SURGEON WAS CONSULTED. A PIGTAIL CATH WAS EXCHANGED WITH A LIMA CATH. WITH THE HELP OF AN ANGLED GLIDEWIRE, THE CATH WAS ADVANCED INTO THE LEFT SFA OVER THE AORTIC ARCH, WAS CROSSED WITH THE HELP OF THE LIMA CATH. DESTINATION 6FRENCH SHEATH WAS ADVANCED OVER THE BIFURCATION OF THE AORTA AND PARKED IN THE COMMON FEMORAL ARTERY. ANTERIOR TIBIAL ARTERY WAS THE ONLY VESSEL BELOW THE POPLITEAL ARTERY WHICH HAD CRITICAL TANDEM STENOSIS THROUGHOUT, WITH VERY POOR FLOW INTO THE FOOT. POSTERIOR TIBIAL ARTERY AS WELL AS THE PERONEAL ARTERY WERE TOTALLY OCCLUDED PROXIMALLY. WAS DECIDED TO PROCEED WITH PTA OF THE LEFT LOWER EXTREMITY. PT STARTED ON ANGIOMAX BOLUS FOLLOWED BY THE DRIP. A BMW WIRE WAS ADVANCED DISTALLY DOWN INTO THE ANTERIOR TIBIAL ARTERY. AT THIS POINT THE WIRE WAS PULLED BACK AND THE COAT OF THE WIRE ACTUALLY CAME OUT WITH THE REST OF THE WIRED UNCOILED, AND WAS LEFT IN THE VESSEL. SEVERAL ATTEMPTS WERE MADE USING DIFFERENT SNARES AND TECHNIQUES, INCLUDING CWIRE USING THE SNARE. EFFORTS FAILED AN INTERVENTIONAL RADIOLOGIST AND VASCULAR SURGEON WERE CONSULTED. THE VASCULAR SURGEON WAS ABLE TO EXTRACT THE WIRE WITH A MICROSNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80920 HI -TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE BMW DQX ABBOTT VASCULAR 2102771

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention