BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SWAN GANZ

    MDR report key: 134219 · Received November 20, 1997

    Report

    Report Number
    134219
    Event Type
    Injury
    Date Received
    November 20, 1997
    Date of Event
    November 5, 1997
    Report Date
    November 17, 1997
    Manufacturer
    BAXTER EDWARDS LABORATORIES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A SWAN-GANZ CATHETER PLACED ON OCT 18, 1997. THE SWAN-GANZ WAS REMOVED ON OCT 22, 1997 AND REPLACED WITH A TRIPLE LUMEN CATHETER. THE PROCEDURE WENT SMOOTHLY PER MD'S WHO REMOVED THE CATHETER. DURING PT NEXT ADMISSION A SINGLE CHEST X-RAY WAS DONE ON NOV 5, 1997. A PORTION OF THE SWAN-GANZ CATHETER WAS PRESENT IN THE RIGHT ATRIUM. A PERCUTANEOUS TRANSVASCULAR FOREIGN BODY RETRIEVAL WAS PERFORMED UNDER FLUOROSCOPY. A FRAGMENTED SEGMENT OF THE CATHETER WAS REMOVED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SWAN GANZ Implant THERMODILUTION PACE PORT CATHETER DYG BAXTER EDWARDS LABORATORIES 93A-931H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention