BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFS STYLET, 6F, 12CM

    MDR report key: 6517800 · Received April 25, 2017

    Report

    Report Number
    2183870-2017-00186
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 27, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K052003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: CURRENT TECHNIQUES TO TREAT PATHOLOGIC PERFORATOR VEINS (J VASC SURG: VENOUS AND ENDOVENOUS TECHNIQUES JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS VOLUME 5, NUMBER 2 OZSVATH ET AL MARCH 2017 VENOUS AND LYM DIS 2017;5:293-6.). HTTP://DOI.ORG/10.1016/J.JVSV.2016.10.085.

    Description of Event or Problem · 1

    A STUDY WAS CONDUCTED TO COMPARE CURRENT TECHNIQUES TO TREAT PATHOLOGIC PERFORATOR VEINS. ONE OF THE TECHNIQUES OBSERVED WAS RADIOFREQUENCY ABLATION OF REFLUXING PERFORATOR VEINS IN THE LOWER EXTREMITY USING A RF STYLET. A SAMPLE OF RESULTS FROM THE TECHNIQUE WERE PRESENTED IN THE STUDY. COMPLICATIONS INCLUDED; NEURAPRAXIA, 0.6%, CHEMICAL ULCER, 0.6%, DVT, 0.6%, PHLEBITIS, 0.6%, CELLULITIS, 0.6%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302521 RFS STYLET, 6F, 12CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization