BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 1081411 · Received July 23, 2008

    Report

    Report Number
    MW5007784
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 20, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SUCCESSFUL PTA OF THE RIGHT RENAL ARTERY; HOWEVER, THE PT HAD SHEARING OFF OF THE WIRE. SEVERAL ATTEMPTS WERE MADE FOR RETRIEVAL, HOWEVER, WAS UNSUCCESSFUL. THE PT HAD TO UNDERGO AN ADD'L PROCEDURE FOR LOCAL FEMORAL ARTERECTOMY/RETRIEVAL AND REMOVAL OF RETAINED WIRE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RENAL ARTERY STENOSIS. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT BALANCE MIDDLEWEIGHT GUIDE WIRE DQX ABBOTT VASCULAR 8032481

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability