BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 513689 · Received February 27, 2004

    Report

    Report Number
    6000002-2004-00034
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 2, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY AFTER CLEARING FISTULA THE WINDINGS AND THE BALLOON CAME OFF IN THE PT WHILE PULLING THE ARTERIAL PLUG BACK IN THE GRAFT. THE DR USED CONTRAST, AND A 7FR INTRODUCER FOR AN HOUR TO TRY TO FIND THE BALLOON, HOWEVER, WAS UNSUCCESSFUL. THE PT IS REPORTEDLY FINE AND HAS BEEN RELEASED FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120804F 513GC249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention