BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER

    MDR report key: 1132432 · Received July 28, 2008

    Report

    Report Number
    1132432
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 28, 2008
    Manufacturer
    EDWARD LIFESCIENCES, LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING CARDIOPULMONARY RESUSCITATION. PATIENT WAS BRADYCARDIC AND HAD WHAT APPEARED TO BE AN ACUTE INFERIOR MYOCARDIAL INFARCTION. IT WAS ELECTED TO TRY PACING THE PATIENT. A RIGHT INTERNAL JUGULAR SHEATH INTRODUCER WAS PLACED BY SELDINGER TECHNIQUE BY ULTRASOUND GUIDANCE. A SWAN-GANZ BIPOLAR PACING CATHETER WAS CHECKED PRIOR TO ATTEMPTING PLACEMENT. IT WAS PLACED, HOWEVER THE BALLOON WOULD NOT INFLATE. A DELAY OF CARE RESULTED BECAUSE IT WAS NECESSARY TO INSERT A SECOND PACING CATHETER. HOWEVER, THIS OCCURRENCE DID NOT CONTRIBUTE TO THE PATIENT'S OUTCOME. THE INABILITY OF THE BALLOON TO INFLATE RESULTED IN PERFORMANCE DELAY. AFTERWARDS THE PACKAGING OF THE PACING CATHETER WAS EXAMINED AND IT WAS NOTED THAT THE "USE BY" DATE HAD EXPIRED. THE INVENTORY WAS INSPECTED TO ASSURE THE REMAINING PRODUCT WAS NOT OUTDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER CATHETER, PULMONARY ARTERY DYG EDWARD LIFESCIENCES, LLC * 236AC049

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR