BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 6848671 · Received September 7, 2017

    Report

    Report Number
    2134265-2017-09157
    Event Type
    Injury
    Date Received
    September 7, 2017
    Report Date
    August 28, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUI, C.H ET AL. ¿¿RADIOFREQUENCY ABLATION OF HEPATIC METASTASES: FACTORS INFLUENCING LOCAL TUMOR PROGRESSION¿. OFFICAL JOURNAL OF THE SOCIETY IF SURGICAL ONCOLOGY.(2014) 21:3090-3095.DEVICE EVALUATED BY MANUFACTURER: 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 THAT MINOR PATIENT COMPLICATIONS OCCURRED POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. THE COMPLICATIONS INCLUDED A SMALL ASYMPTOMATIC PNEUMOTHORACES,SMALL PERIHEPATIC HEMATOMAS, A RELATIVELY SMALL PLEURAL EFFUSION AND A SMALL PERI-HEPATIC BILOMA. ALL MINOR COMPLICATIONS WERE MANAGED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628427 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001262230

    Patients

    Seq Age Sex Outcome Treatment
    1