BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1082690 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08082
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 1, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, THERE IS OBVIOUS SPLIT IN THE FRONT AREA OF TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120804FF 58442251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK