BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 440929 · Received January 30, 2003

    Report

    Report Number
    MW1027401
    Event Type
    Malfunction
    Date Received
    January 30, 2003
    Date of Event
    January 21, 2003
    Report Date
    January 30, 2003
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LEFT ARM AV - ARTERIOVENOUS FISTULA THROMBECTOMY WITH USE OF A FOGARTY BALLOON CATHETER, BALLOON TIP OF FOGARTY CATH APPEARS TO HAVE BEEN RETAINED IN A TORTUOUS VENOUS BRANCH WHEN THE BALLOON ITSELF WAS PULLED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER DXE EDWARD LIFESCIENCES LLC 120804F 512JC327

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INTRAOPERATIVE USE. 2ND FOGARTY FROM SAME LOT USED| WITHOUT INCIDENT.