BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR BMW WIRE

    MDR report key: 3040098 · Received April 1, 2013

    Report

    Report Number
    MW5029626
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A BROKEN IR GUIDE WIRE (THREE SEGMENTS TOTALED 48.0 CM / 21.8 FL IN LENGTH) WAS FOUND IN (B)(6) LEFT ARM DURING VASCULAR SURGERY TO CREATE AN AV FISTULA (AVF). PRELIMINARY REVIEW INDICATES THE GUIDE WIRE WAS LOST DURING THE IR PROCEDURE ON (B)(6) /2013. THIS WAS FOUND THROUGH RETROSPECTIVE REVIEW THROUGH QUALITY MGMT; DISCOVERED ON (B)(6) 2013. UNEXPECTED EVENT WITHIN THE STANDARD OF CARE. REASON FOR USE: CHRONIC KIDNEY DISEASE - HTN, CLOTTED AVF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131816 ABBOTT VASCULAR BMW WIRE 0.014 190 CM DQX ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention