BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CATHETER

    MDR report key: 5010560 · Received August 18, 2015

    Report

    Report Number
    5010560
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 10, 2015
    Report Date
    August 5, 2015
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN EDWARDS VIP SWAN GANZ CATHETER WAS IN THE LEFT IJ CORDIS. AFTER WEDGE WAS PERFORMED, THE SYRINGE DID NOT DEFLATE AND RELEASE AIR. THEN THE SYRINGE WAS PULLED BACK ON TO ENSURE THE BALLOON WAS DEFLATED AND BLOOD RETURN WAS NOTED IN SYRINGE. THE SWAN GANZ CATHETER WAS REMOVED AND BALLOON RUPTURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543774 SWAN-GANZ CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, LLC 831F75 59757969

    Patients

    Seq Age Sex Outcome Treatment
    1