BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS MEDICAL TECHNOLOGIES, INC.

    MDR report key: 2274778 · Received September 30, 2011

    Report

    Report Number
    2274778
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    VNUS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH HYPERTENSION PRESENTS FOR TREATMENT OF LEFT LOWER EXTREMITY (LLE) VARICOSE VEIN BY RADIOFREQUENCY ABLATION (RFA). ONE END OF THE RFA CATHETER WAS INSERTED INSIDE THE LLE VEIN AND THE OTHER END OF THE RFA CATHETER WAS ATTACHED TO A LOANER VNUS RFA GENERATOR. THE RFA GENERATOR WAS POWERED ON AND APPARENTLY SELF-ACTIVATED THE HANDPIECE WITHOUT HUMAN INTERVENTION. THE IRRIGATION FLUID HAD NOT YET BEEN STARTED. THE RFA CATHETER WAS NOT LOCATED IN THE INTENDED VEIN AREA WHEN THE ACTIVATION OCCURRED. THE RFA GENERATOR WAS IMMEDIATELY POWERED OFF. THE RFA GENERATOR WAS AGAIN POWERED ON, WITH THE SAME TUBING ATTACHED, AND IRRIGATION FLUID STARTED. THE MACHINE WAS THEN USED SUCCESSFULLY FOR THE LENGTH OF THE PROCEDURE. RFA GENERATOR TUBING WAS NOT SAVED UPON COMPLETION OF THE PROCEDURE; LOT NUMBER UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNUS MEDICAL TECHNOLOGIES, INC. RADIOFREQUENCY (RF) GENERATOR GEI VNUS RFG2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other