BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1030819 · Received April 17, 2008

    Report

    Report Number
    6000002-2008-06579
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    November 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER #1 LEAK TESTING CONFIRMED LEAKAGE FROM THE INFLATION LUMEN DUE TO A SPLIT 0.110" LONG AT THE DISTAL EDGE OF THE THERMAL FILAMENT (MIDDLE FORM). THE TUBING SPLIT ENTERS THE INFLATION LUMEN. CATHETER #2 LEAK TESTING CONFIRMED LEAKAGE FROM THE INFLATION LUMEN DUE TO TWO SPLITS 0.012" AND .005" LONG AT THE DISTAL EDGE OF THE THERMAL FILAMENT (MIDDLE FORM). THE TUBING SPLITS ENTER THE INFLATION LUMEN. CATHETER #3 LEAK TESTING CONFIRMED LEAKAGE FROM THE INFLATION LUMEN DUE TO A SPLIT 0.090" LONG AT THE DISTAL EDGE OF THE THERMAL FILAMENT (MIDDLE FORM). THE TUBING SPLIT ENTERS THE INFLATION LUMEN. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE OBSERVED FROM THE BALLOON. NO PT COMPLICATIONS WERE REPORTED. ONE CATHETER WAS REPORTED, THREE CATHETERS WERE RETURNED FOR EVAL.

    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 774HF75 58345848

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other