BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 6811678 · Received August 22, 2017

    Report

    Report Number
    2134265-2017-08514
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    August 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PALUSSIERE, JEAN ET AL. ¿PERCUTANEOUS LUNG THERMAL ABLATION OF NON-SURGICAL CLINICAL N0 NON-SMALL CELL LUNG CANCER: RESULTS OF EIGHT YEARS' EXPERIENCE IN 87 PATIENTS FROM TWO CENTERS.¿ CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2015) 38:160¿166 DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENTS EXPERIENCED COMPLICATIONS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. IMMEDIATE PROCEDURAL COMPLICATIONS AFTER RFA PROCEDURE WERE REPORTED AS PNEUMOTHORAX AND NEUROLOGICAL (GRADE III OR IV) COMPLICATIONS OCCURRED IN THE LOWER TRUNK OF THE BRACHIAL PLEXUS AFTER RFA OF APICAL TUMORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591424 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MAPLE GROVE M001262230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention