BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1011935 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06170
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT BALLOON LUMEN LEAKAGE WAS OBSERVED THROUGH A SLIT, 0.13 INCHES IN LENGTH, AT THE 12 CM AREA (DISTAL OF THERMAL FILAMENT). NO VISIBLE DAMAGE OBSERVED TO THE BALLOON LATEX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AND THE BALLOON COULD NOT MAINTAIN INFLATION AT THE INFLATION TEST. 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 774HF75 58418556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other