BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR INCORPORATED

    MDR report key: 2740447 · Received September 7, 2012

    Report

    Report Number
    MW5026835
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    June 21, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ABBOTT VASCULAR INCORPORATED
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PLACE RENAL ARTERY STENT THE GLIDE WIRE GOT STUCK IN THE STENT AND A PIECE BROKE OFF IN THE PT. THE PIECE WAS UNRETRIEVABLE AND LEFT IN. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR INCORPORATED UNIVERSAL GUIDEWIRE / HI TORQUE BALANCE DQX ABBOTT VASCULAR INCORPORATED 0.014CM 2030271

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR