BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY ADHERENT CLOT CATHETER (ACC 4/6) - 6MM

    MDR report key: 2163577 · Received July 12, 2011

    Report

    Report Number
    MW5021320
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 22, 2011
    Manufacturer
    EDWARDS LIFESCIENCES LCC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS UNDERGOING A THROMBECTOMY AND REVISION OF HIS RIGHT UPPER EXTREMITY ARTERIOVENOUS GRAFT. THE CATHETER BECAME WEDGED AND THE PROCEDURALIST WAS UNABLE TO REMOVE IT FROM THE DISTAL GRAFT AREA. THE CATHETER WIRE WAS SUBSEQUENTLY REMOVED WITH THE EXCEPTION OF A SMALL RUBBER TIP. THERE WAS GOOD FLOW IN THE GRAFT AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ADHERENT CLOT CATHETER (ACC 4/6) - 6MM ACC DXE EDWARDS LIFESCIENCES LCC 140806 58884701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention