BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 6957897 · Received October 18, 2017

    Report

    Report Number
    2134265-2017-10053
    Event Type
    Injury
    Date Received
    October 18, 2017
    Report Date
    September 22, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: STANG ET AL. "SELECTION CRITERIA FOR RADIOFREQUENCY ABLATION FOR COLORECTAL LIVER METASTASES IN THE ERA OF EFFECTIVE. SYSTEMIC THERAPY: A CLINICAL SCORE BASED PROPOSAL", BMC CANCER 2014, 14:500, HTTP://WWW.BIOMEDCENTRAL.COM/1471-2407/14/500. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT 88 CONSECUTIVE PATIENTS RECEIVED RADIOFREQUENCY ABLATION (RFA) FOR LIVER-ONLY COLORECTAL LIVER METASTASES (CLM) DURING PARTIAL REMISSION (PR), STABLE DISEASE (SD), OR PROGRESSIVE DISEASE (PD) AFTER SYSTEMIC THERAPY. ALL ABLATIONS WERE PERFORMED USING A 15-GAUGE NEEDLE WITH 10 EXPANDABLE HOOK-SHAPED ELECTRODE TINES (LEVEEN) CONNECTED WITH A COMMERCIALLY AVAILABLE RF GENERATOR (RF 3000). THERE WERE NO PROCEDURE-RELATED DEATHS. ADVERSE EVENTS RELATED TO THE PROCEDURE WERE INFECTED BILOMA REQUIRING DRAINAGE AND ANTIBIOTIC THERAPY, FEVER, PAIN, PLEURAL EFFUSION AND A SMALL INTRAHEPATIC HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738164 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention