BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSUREFAST CATHETER

    MDR report key: 1308380 · Received February 2, 2009

    Report

    Report Number
    2953189-2009-00005
    Event Type
    Injury
    Date Received
    February 2, 2009
    Report Date
    February 2, 2009
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED INFO HAS NOT BEEN PROVIDED BY THE INTERNATIONAL DISTRIBUTOR. THE DEVICE(S) WERE DISCARDED AND DETAILS REGARDING THE EVENT(S) HAVE NOT BEEN PROVIDED. WITHOUT SUFFICIENT PROCEDURAL DETAIL FROM THE ATTENDING PHYSICIAN(S), OUR EXPERIENCE INDICATES THAT SKIN BURNS ARE USUALLY CAUSED BY MAINTAINING INADEQUATE DISTANCE BETWEEN THE SKIN SURFACE AND THE ANTERIOR VEIN WALL. THE VNUS CLOSUREFAST INSTRUCTIONS-FOR-USE RECOMMENDS MAINTAINING AT LEAST 1 CM VEIN DEPTH AND WARNS ABOUT THE POTENTIAL FOR SKIN BURNS IF THE SKIN IS NOT PROTECTED WITH FLUID INFILTRATION (TUMESCENCE). SKIN BURN IS A RECOGNIZED COMPLICATION OF ENDOVENOUS ABLATION AND IS ADDRESSED IN THE PRODUCT LABELING. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS RECEIVED SKIN BURNS WHILE BEING TREATED WITH THE CLOSUREFAST CATHETER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention