BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN GANZ THERMODILUTION VIP PLUS CATHETER

    MDR report key: 379203 · Received February 26, 2002

    Report

    Report Number
    6000002-2002-00084
    Event Type
    Other
    Date Received
    February 26, 2002
    Date of Event
    January 26, 2002
    Report Date
    February 1, 2002
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE REPORTED: PT HAD A PULMONARY ARTERY (PA) CATHETER PLACED (LEFT I.J.). PT WAS HEMODYNAMICALLY UNSTABLE. FOLLOWING FLOATATION OF PA CATH INTO PULMONARY CAPILLARY WEDGE PRESSURE, THE BALLOON WAS DEFLATED. THE MONITOR CONTINUED TO SHOW A PULMONARY CAPILLARY WEDGE PRESSURE TRACING. CATHETER WAS PULLED BACK A COUPLE OF CENTIMETERS AND BLOOD PRESS. DROPPED ACUTELY. BRIGHT RED BLOOD NOTED IN THE ETT AND CPR WAS STARTED. PT EXPIRED AFTER 20 MIN EFFORT. IT WAS REPORTED THAT PT EXPIRY WAS NOT ATTRIBUTED TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ THERMODILUTION VIP PLUS CATHETER SWAN-GANZ CATHETER DYG EDWARDS LIFESCIENCES 834HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other