BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVLT PROCEDURE KIT

    MDR report key: 645922 · Received November 12, 2005

    Report

    Report Number
    1225808-2005-00003
    Event Type
    Injury
    Date Received
    November 12, 2005
    Date of Event
    October 13, 2005
    Report Date
    November 11, 2005
    Manufacturer
    DIOMED, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN EVLT PROCEDURE IN 2005 TO THE RIGHT GREATER SAPHENOUS VEIN FOR SAPHENOFEMORAL REFLUX. PT RETURNED EIGHT DAYS LATER FOR A ONE WEEK POST PROCEDURE CHECK AND ULTRASOUND AN APPROXIMATELY 20 CM FRAGMENT OF INTRODUCER SHEATH WAS FOUND IN THE MID TO DISTAL RIGHT GREATER SAPHENOUS VEIN. IT WAS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT PROCEDURE KIT ENDOVENOUS CATHETER FOZ DIOMED, INC. EVLT/PK-02 003870

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention