BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY EMBOLECTOMY CATHETER

    MDR report key: 1082348 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08183
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    BALLOON WAS DETACHED FROM THE CATHETER DURING PROCEDURE. DETACHED BALLOON WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120404F 58426982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK