BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1032180 · Received April 16, 2008

    Report

    Report Number
    6000002-2008-06543
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT DRY BLOOD WAS EVIDENT INSIDE THE THERMISTOR CONNECTOR AND THE THERMISTOR LUMEN. TWO DIFFERENT SLITS WERE FOUND ON THE CATHETER BODY. THE FIRST SLIT, ABOUT 0.04 INCHES LONG, WAS FOUND AT THE PROXIMAL END OF THERMAL FILAMENT. THE SECOND SLIT, ABOUT 0.014 INCHES LONG, WAS FOUND AT THE DISTAL END OF THERMAL FILAMENT. DRY BLOOD WAS ALSO VISIBLE AT BOTH OF THE SLITS. THE SLITS ENTERED THE THERMISTOR LUMEN. IT WAS APPARENT THAT BLOOD LEAKED INTO THERMISTOR LUMEN THROUGH THE SLITS AND TRAVELED UP TO THERMISTOR CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE WAS OBSERVED AT 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 746HF8 58442249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other