BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2140519 · Received June 21, 2011

    Report

    Report Number
    MW5021113
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABBOTT VASCULAR .014 IRONMAN GUIDEWIRE. DURING PROCEDURE DISTAL TIP OF GUIDEWIRE SEPARATED FROM BODY OF WIRE. UNABLE TO RETRIEVE WIRE FRAGMENT. FRAGMENT MIGRATED DISTALLY AND BECAME LODGED IN THE DEEP (PROFUNDA) FEMORAL ARTERY. IT WAS DETERMINED AT THAT TIME THAT WIRE FRAGMENT WOULD CAUSE NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR HI-TORQUE IRON MAN .014 GUIDEWIRE DQX ABBOTT VASCULAR 0120101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR