BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY CATHETER FOR ARTERIAL EMBOLECTOMY

    MDR report key: 2211451 · Received August 10, 2011

    Report

    Report Number
    MW5021704
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 4, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USED 4 FRENCH FOGARTY CATHETERS TO TAMPONADE A BLEED IN RIGHT BRONCHUS INTERMEDIUS; WHITE TIP OF CATHETER CAME OUT OF THE TIP OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY CATHETER FOR ARTERIAL EMBOLECTOMY 4F EMB80 DXE EDWARDS LIFESCIENCES 59005430

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention