BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1011920 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06173
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT THE CATHETER WAS CONFIRMED TO HAVE LEAKAGE INTO THE THERMISTOR CONNECTOR. THE CATHETER BODY WAS FOUND TO HAVE A SLIT 0.130 INCHES LONG AT THE DISTAL END OF THE MIDDLE FORM OR THERMAL FILAMENT AREA. THE TEAR ENTERED THE THERMISTOR LUMEN AT THAT POINT. THERE WERE ALSO TWO 70CC2 CABLES RETURNED WITH THE CATHETER AND BOTH WERE TESTED USING THE VIGILANCE II MONITOR. BOTH WERE FOUND TO PASS THE CABLE TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD CAME UP THROUGH THE CARDIAC OUTPUT LUMEN. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other