BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIO FREQUENCY STYLET CATHETER (RFS)

    MDR report key: 1632352 · Received March 12, 2010

    Report

    Report Number
    2953189-2010-00004
    Event Type
    Injury
    Date Received
    March 12, 2010
    Report Date
    February 17, 2010
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K052003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, TWO ATTEMPTS HAVE BEEN MADE TO GATHER MORE INFO ON THIS CASE. NO FURTHER INFO IS AVAILABLE ON THIS INCIDENT. SKIN BURNS ARE A KNOWN COMPLICATION OF VENOUS ABLATION. 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 PATH. THIS INJECTION IS INTENDED TO ACCOMPLISH TWO IMPORTANT RESULTS: IT PROVIDES PROTECTION FOR THE PT AGAINST ANY PAIN THAT MAY BE ASSOCIATED WITH THE PROCEDURE, AND IT ASSURES THAT THE VEIN TO BE TREATED IS DEPRESSED AND MAINTAINED AT LEAST ONE TO TWO CENTIMETERS FROM THE SKIN SURFACE. THE PRODUCT'S INSTRUCTIONS-FOR-USE PROVIDED GUIDELINES FOR THE PROPER ADMINISTRATION OF TUMESCENT INFILTRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B) (6) 2010 THAT A SKIN BURN OCCURRED USING A VNUS RFS VENOUS ABLATION DEVICE. THE PT SHOWED A SKIN BURN ON HIS LEG TO A VNUS EMPLOYEE AND STATED THAT THE SKIN BURN HAPPENED AFTER HIS LAST VENOUS ABLATION TREATMENT. FROM THE PT'S DESCRIPTION, THE SKIN BURN MIGHT HAVE RESULTED IN AN INFECTION. NO ADD'L INFO IS AVAILABLE ABOUT THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIO FREQUENCY STYLET CATHETER (RFS) RADIO FREQUENCY CATHETER GEI VNUS MEDICAL TECHNOLOGIES, INC. RFS2-6-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention