BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 1649957 · Received March 30, 2010

    Report

    Report Number
    2953189-2010-00005
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    December 1, 2009
    Report Date
    March 5, 2010
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THREE ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFO ON THIS ADVERSE EVENT. ATTEMPTS WERE MADE ON 03/05/10, 03/15/10, AND 03/25/10. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. NERVE DAMAGE IS A RECOGNIZED COMPLICATION OF VENOUS ABLATION THERAPY THAT IS DESCRIBED IN THE PRODUCT INSTRUCTIONS-FOR-USE (IFU). PER THE IFU, NERVE INJURY MAY OCCUR FROM THERMAL DAMAGE TO ADJACENT SENSORY NERVES. RISK OF NERVE INJURY MAY BE HIGHER WITH TREATMENT AT OR BELOW THE CALF, OR WITHOUT PERIVENOUS FLUID INFILTRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON MARCH 5, 2010 THAT A PT WHO WAS TREATED WITH A CLOSURE RF ABLATION DEVICE IN (B) (6) 2009, SUSTAINED AN INJURY TO THE FEMORAL NERVE. POST-OPERATIVELY, THE PT EXPERIENCED WEAKNESS IN THE QUADRICEPS MUSCLE GROUP AND NOW USES A CANE TO ASSIST HER WITH WALKING. THE LOCATION OF THE NERVE IS LATERAL TO THE PROXIMAL GSV/SFJ AREA AND THE FEMORAL ARTERY IS BETWEEN THESE TWO STRUCTURES. PHYSICIAN STATED THE PT'S SYMPTOMS WERE IMPROVING. NO ADDITIONAL INFO IS AVAILABLE ON THIS ADVERSE EVENT AT THIS POINT IN TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other