BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY EMBOLECTOMY CATHETER

    MDR report key: 1013222 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06145
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    INFORMED BY VASCULAR THEATRE, WHEN THE BALLOON ON THE EMBOLECTOMY CATHETER WAS INFLATED, IT WOULD NOT COME DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120602F 58400080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK