BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SHEATH 6FR

    MDR report key: 3006096 · Received February 28, 2013

    Report

    Report Number
    3006096
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    A 6FR SHEATH WAS INSERTED INTO THE PATIENT. IT WAS THEN NOTICED THAT AT THE DIAPHRAM OF THE SHEATH THERE WAS BLOOD COMING OUT OF THE PORT. A WIRE WAS INSERTED AND THE SHEATH WAS EXCHANGED FOR A NEW ONE (DIFFERENT LOT# AND IT WORKED FINE).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ANGIOGRAM (HRT CATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87460 SUPER SHEATH 6FR INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC 16035-06B 12416B1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES