BEUDAMED
    FDA Adverse Event Death Summary report: N

    8 FRENCH BIG MAX GUIDING CATHETER

    MDR report key: 27351 · Received July 25, 1995

    Report

    Report Number
    27351
    Event Type
    Death
    Date Received
    July 25, 1995
    Date of Event
    February 27, 1995
    Report Date
    March 14, 1995
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ANGIOPLASTY, ON 2ND INFLATION OF BALLOON, THE PROXIMAL RIGHT CORONARY ARTERY & ASCENDING AORTA DISSECTED. THIS NECESSITATED OPEN HEART SURGERY & THE PT DIED IMMEDIATELY FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 FRENCH BIG MAX GUIDING CATHETER Implant GUIDING CATHETER DYB SCIMED LIFE SYSTEMS, INC. JR4 & JR3.5 & AR-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death BAXTER TREK EXCHANGE GUIDEWIRE| BAXTER BALLOON CATHETER 3.5 DISTANCE