BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVLT OPTICAL FIBER

    MDR report key: 676500 · Received February 15, 2006

    Report

    Report Number
    1225808-2006-00001
    Event Type
    Injury
    Date Received
    February 15, 2006
    Date of Event
    January 11, 2006
    Report Date
    February 11, 2006
    Manufacturer
    DIOMED, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTE IN THE MIDDLE TO THE PROCEDURE, LIGHT WAS VISIBLE IN MORE THAN MORE PLACE. HE STOPPED THE PROCEDURE AND PULLED THE FIBER AND SHEATH OUT AND NOTICED IT WAS SHORTER THAN IT SHOULD BE. UNDER ULTRASOUND, HE COULD VISUALIZED PIECES OF THE FIBER STILL IN THE GREATER SAPHENOUS VEIN. A SMALL INCISION WAS MADE AND THE TWO PIECES WERE RETRIEVED. ONE PIECE WAS ABOUT 2 AND 1/2 INCHES WITH THE OTHER ABOUT 6 INCHES. REMAINING PROCEDURES PROCEEDED AS EXPECTED. PATIENT RECOVERY WAS UNEVENTUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT OPTICAL FIBER INTERVASCULAR OPTICAL FIBER GEX DIOMED, INC. EVLT/PK-02 003870

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention