BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1011917 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06169
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT THE CATHETER BODY WAS FOUND TO HAVE A SLIT 0.070 INCHES LONG THAT ENTERED THE THERMISTOR LUMEN. THE SLIT WAS LOCATED AT THE PROXIMAL END OF THE (MIDDLE FORM) THERMAL FILAMENT AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE OBSERVED FROM THE THERMISTOR. 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