BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1082684 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08085
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 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 THE CATHETER TIP IS EASILY BENT (NOT EASY FOR CROSSING) AND THE BALLOON TENDS TO BE REMOVED AND LOOSEN FROM THE CATHETER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120804FF 58482524

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK