BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY

    MDR report key: 54387 · Received August 1, 1996

    Report

    Report Number
    54387
    Event Type
    Other
    Date Received
    August 1, 1996
    Date of Event
    January 16, 1996
    Report Date
    February 2, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DECLOTTING THE LEFT FEMORAL A-V GRAFT THE EMBOLECTOMY CATHETER WAS BEING USED. WHEN THE CATHETER WAS REMOVED FROM THE FEMORAL LOOP. THE BALLOON WAS NO LONGER ATTACHED TO THE END OF THE CATHETER. THE ARTERIAL SYSTEM WAS EXTENSIVELY EXPLORED AND THE ANGIOSCOPE WAS USED TO VISUALIZE IT. THE BALLOON WAS NOT FOUND. TO THIS DATE THE PT HAS NOT REPORTED ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ATERIAL EMBOLECTOMY CATHETER DXE BAXTER HEALTHCARE CORP. 120804F 5W03L

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other