BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER PERIPHERALS 600 MICRON BARE LASER FIBER

    MDR report key: 746742 · Received September 15, 2005

    Report

    Report Number
    MW1036698
    Event Type
    Other
    Date Received
    September 15, 2005
    Date of Event
    May 23, 2005
    Report Date
    September 15, 2005
    Manufacturer
    LASER PERIPHERALS
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ENDOVENOUS LASER ABLATION WAS PERFORMED ON PT. THE RIGHT GSV AND RIGHT GSV-ACCESSORY WERE PERCUTANEOUSLY ACCESSED IN THE KNEE REGION FOLLOWED BY PASSAGE OF A 45-CM 5FR CATHETER OVER A .035 INCH GUIDEWIRE WHICH ALLOWED FOR PASSAGE OF A 600 MICRON LASER FIBER TO 1CM DISTAL TO THE SFJ. DUPLEX ULTRASOUND WAS USED TO VERIFY LASER FIBER POSITION AS WELL AS PERCUTANEOUS INSTILLATION OF A CONCENTRIC RING OF TUMESCENT LOCAL ANESTHESIA ALONG THE COURSE OF CANNULATED R-GSV AND R-GSV-ACC VEINS. SEQUENTIAL LASERING OF THE GSV AND GSV-ACC LIKELY CAUSED HEAT-RELATED INJURY OF ONE LASER FIBER THAT WAS 'CROSSED OVER' AT CLOSE ENOUGH PROXIMITY BY THE FIRST CONTINUOUSLY FIRED LASER FIBER SUCH THAT A 3.8 CM REMNANT OF DISTAL LASER FIBER TIP WAS LEFT IN THE PROXIMAL GSV. AT 3 MONTHS POST-EVLA A DUPLEX U/S PERFORMED BY DR REVEALED THE RETAINED LASER FIBER TIP. PT HAS NO SYMPTOMS AND THE CLOSED -SCLEROSED-PROXIMAL GSV CONTAINING THE LASER FIBER TIP POSES NO PROBLEM OR NEED FOR EXCISION AND REMOVAL SINCE THE LASER FIBER TIP IS INERT AND BIOCOMPATIBLE. IN THIS CASE, THE RISKS OF REMOVAL ARE QUITE SIGNIFICANT AND PT UNDERSTANDS LEAVING THE LASER FIBER TIP IN THE CLOSED OFF EVLA-TREATED PROXIMAL GSV SHOULD POSE NO DANGER AT THIS TIME. ULTRASOUND ASSESSEMENT IN SIX MONTHS WILL BE PERFORMED TO REASSESS THE INDWELLING LASER FIBER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER PERIPHERALS 600 MICRON BARE LASER FIBER BARE LASER FIBER FOR DIOMED ENDOVENOUS LASER GEX LASER PERIPHERALS DBLF-60 LP-338

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other