BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATH

    MDR report key: 180158 · Received July 30, 1998

    Report

    Report Number
    6000002-1998-00206
    Event Type
    Injury
    Date Received
    July 30, 1998
    Date of Event
    June 30, 1998
    Report Date
    July 27, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE MAY HAVE BEEN A PULMONARY ARTERY RUPTURE. A FRAIL CARDIAC PT UNDERWENT A CORONARY ARTERY BYPASS AND VALVE PROCEDURE. PT WAS MOVED TO SURGICAL INTENSIVE CARE UNIT AND STABILIZED. CATHETER FUNCTIONED APPROPRIATELY. CATHETER WAS WEDGED, PT BEGAN TO COUGH FROTHY BLOOD. PT WAS VENTILATED AND MOVED TO INTENSIVE CARE UNIT. PT WAS DISCHARGED ON 7/1/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATH CONTINUOUS CARDIAC OUTPUT CATHETER DXG BAXTER HEALTHCARE CORP. 139HF75 158B0673

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention