BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 1544424 · Received November 19, 2009

    Report

    Report Number
    2953189-2009-00019
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    October 21, 2009
    Report Date
    October 21, 2009
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INITIAL KNOWLEDGE OF THIS SKIN BURN COMPLAINT, THE CLINICAL MARKETING DEPARTMENT WAS IMMEDIATELY ALERTED OF THE REPORTED CONDITION. THE PHYSICIAN WAS PROVIDED WITH ADDITIONAL TRAINING AND A FOLLOW-UP WITH THE PHYSICIAN WILL OCCUR. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER, AND A REVIEW OF THE DHR INDICATED THAT ALL PRODUCTS MET REQUIRED SPECIFICATION AT THE TIME OF RELEASE. AT THE LAST FOLLOW UP, THE PATIENT'S CONDITION WAS NOTED AS EXCELLENT. PLEASE NOTE THAT SKIN BURNS ARE A KNOWN COMPLICATION OF VENOUS ABLATION, AND ARE ALWAYS ASSOCIATED WITH USER TECHNIQUE. PROPER USE OF THE PRODUCT REQUIRES A PROCEDURE KNOWN AS TUMESCENCE. TUMESCENCE, IS ACCOMPLISHED BY INFILTRATING AN ANESTHETIC SOLUTION INTO TISSUE ABOVE THE VEIN TO BE TREATED AT VARIOUS POINTS ALONG THE TREATMENT PATH. THIS INJECTION IS INTENDED TO ACCOMPLISH TWO IMPORTANT RESULTS: IT PROVIDES PROTECTION FOR THE PATIENT AGAINST ANY PAIN THAT MAY BE ASSOCIATED WITH THE PROCEDURE, AND MOST IMPORTANTLY, IT ASSURES THAT THE VEIN TO BE TREATED IS DEPRESSED AND MAINTAINED AT LEAST ONE TO TWO CENTIMETERS FROM THE SKIN SURFACE. THIS DISTANCE HAS BEEN SHOWN NECESSARY TO PREVENT SKIN BURNS. VNUS' CLINICAL EXPERIENCE WITH RADIOFREQUENCY VENOUS ABLATION TREATMENTS INDICATES THAT SKINS BURNS ARE ALWAYS CAUSED BY MAINTAINING INADEQUATE DISTANCE BETWEEN THE SKIN SURFACE AND THE ANTERIOR VEIN WALL. THE PRODUCT'S INSTRUCTIONS-FOR-USE CLEARLY PROVIDES GUIDELINES FOR THE PROPER ADMINISTRATIONS OF TUMESCENT INFILTRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A SKIN BURN AFTER BEING TREATED WITH CLOSUREFAST CATHETER. THE PATIENT WAS COMPLAINING OF PAIN IN THE TREATED AREA, AND THE PHYSICIAN PRESCRIBED AVELOX AND SILVADENE. THE PHYSICIAN ALSO PERFORMED A SKIN AND SUBCUTANEOUS TISSUE EXCISION DOWN TO THE HEALTHY TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST CATHETER ELECTROSURGICAL CUTTING AND COAGULATION GEI VNUS MEDICAL TECHNOLOGIES, INC. CF7-7-60 474194

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention