BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1021582 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06341
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION REVEALED DRY BLOOD THAT WAS EVIDENT INSIDE THE THERMISTOR CONNECTOR AND THE THERMISTOR LUMEN. A SLIT, ABOUT .11 INCHES LONG, WAS FOUND AT DISTAL END OF THE THERMAL FILAMENT. THE SLIT ENTERED THE THERMISTOR LUMEN. IT WAS APPARENT THAT BLOOD LEAKED INTO THERMISTOR LUMEN THROUGH THE SLIT AND TRAVELED UP TO THE THERMISTOR CONNECTOR. A CAPA IS IN PROCESS FOR CATHETER BODY SLIT RELATED TO BLOOD LEAKAGE AT THE THERMISTOR CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE WAS OBSERVED FROM THE THERMISTOR CONNECTOR. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 777HF8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other