BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2649541 · Received June 26, 2012

    Report

    Report Number
    2649541
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    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 (PULMONARY ARTERY) PRESSURE UNCHANGED VS. UNCHANGED. NO UNTOWARD REACTION NOTED FROM THE PATIENT. DOCTOR 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 * CATHETER, FLOW DIRECTED, SWAN-GANZ DYG EDWARDS LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR