BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARI-LASE BRIGHT TIP FIBER

    MDR report key: 2579978 · Received May 18, 2012

    Report

    Report Number
    2134812-2012-00020
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 18, 2012
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BRIGHT TIP FIBER WAS USED IN A CLINICAL PROCEDURE FOR THE BILATERAL ENDOVENOUS TREATMENT OF THE GREATER SAPHENOUS VEINS. THE PROCEDURE WAS PERFORMED ON THE PATIENT'S RIGHT LEG; THE PHYSICIAN THEN PROCEEDED TO THE LEFT LEG USING THE SAME KIT COMPONENTS. UPON PLACEMENT OF THE DEVICES, VISUALIZATION OF THE AIMING BEAM COULD NOT BE CONFIRMED. THE LASER WAS FIRED BEFORE FIBER PLACEMENT WAS CONFIRMED USING ULTRASOUND. ONCE THE LASER HAD BEEN FIRED FOR SOME TIME, THE AIMING BEAM COULD BE CONFIRMED APPROXIMATELY 6CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ). UPON COMPLETION OF TREATMENT IS WAS OBSERVED THAT THE SHEATH WAS MISSING APPROXIMATELY 14CM OF THE TIP. THE LASER FIBER REMAINED INTACT WITH NO VISUAL DAMAGE. SCANS CONFIRMED THAT THE SHEATH REMAINED IN THE PATIENT (APPROXIMATELY MID THIGH) AND THAT THE VESSEL HAD THROMBOSED. NO FURTHER PATIENT IMPACT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARI-LASE BRIGHT TIP FIBER LASER FIBER- STANDARD PROCEDURE KIT GEX VASCULAR SOLUTIONS, INC. 7106 551725

    Patients

    Seq Age Sex Outcome Treatment
    1