BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS

    MDR report key: 2444174 · Received February 3, 2012

    Report

    Report Number
    MW5024162
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 3, 2012
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SWAN GANZ BALLOON CATHETER NOTED WITH BACK BLOOD FLOW AFTER TRYING TO WEDGE BUT UNABLE TO WEDGE, CATHETER CLAMPED, PA PRESSURE UNCHANGED, VS UNCHANGED, NO UNTOWARD REACTION NOTED FROM THE PT. DR. MADE AWARE AND SAID TO KEEP THE SWAN IN AND KEEP THE BALLOON PORT CLAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SWAN GANZ DYG EDWARDS LIFE SCIENCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR