BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 724130 · Received May 30, 2006

    Report

    Report Number
    MW1039388
    Event Type
    Injury
    Date Received
    May 30, 2006
    Report Date
    April 10, 2006
    Manufacturer
    TOTAL VEIN SOLUTIONS
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD ENDOVENOUS LASER ABLATION TO LEFT LEG (GREATER SAPHENOUS VEIN TRIBUTARY + PERFORATOR) IN MD'S OFFICE. DEVELOPED ERYTHEMATOUS, SWOLLEN LEFT THIGH POST PROCEDURE. NEGATIVE DVT ON ULTRASOUND, ULTRASOUND REPEATED + NOTED FOREIGN BODY IN GREATER SAPHENOUS VEIN. RETURNED TO OR FOR REMOVAL OF FRACTURED LASER FIBER SHEATH. IT WAS FOUND INTACT IN THE ENDOVENOUS ABLATED VEIN IN THE MID-THIGH. IT HAD BEEN SHEARED OFF TOTALLY. APPROPRIATELY TRANSECTED, SEPARATED TOGETHER AND CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER SHEATH GEX TOTAL VEIN SOLUTIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention