BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 6811491 · Received August 22, 2017

    Report

    Report Number
    2134265-2017-08528
    Event Type
    Death
    Date Received
    August 22, 2017
    Report Date
    August 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    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).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT 29 DAYS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES A PATIENT EXPIRED DUE TO RESPIRATORY AND MULTIVISCERAL FAILURE AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591677 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001262230

    Patients

    Seq Age Sex Outcome Treatment
    1 Death