BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN GANZ CCO CATHETER

    MDR report key: 799841 · Received December 3, 2004

    Report

    Report Number
    6000002-2004-00454
    Event Type
    Other
    Date Received
    December 3, 2004
    Date of Event
    October 19, 2004
    Report Date
    October 22, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER KNOTTING IS AN INDICATED PRECAUTION IN THE DIRECTIONS FOR USE (DFU) FOR THE MODEL 139HF75 SWAN-GANZ CATHETER. THE DFU PROVIDES SUGGESTIONS TO PREVENT AND CORRECT CATHETER KNOTTING.

    Description of Event or Problem · 1

    REPORTEDLY, THE CATHETER BODY BECAME KNOTTED IN THE PT'S VASCULATURE. THE PT WAS TRANSPORTED TO AN OPERATING ROOM WHERE THE PHYSICIAN POSITIONED THE CATHETER IN THE SUBCLAVIAN, AND THEN MADE A "LITTLE" INCISION TO REMOVE THE CATHETER. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ CCO CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DXG EDWARDS LIFESCIENCES 139HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention