BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 6833881 · Received August 31, 2017

    Report

    Report Number
    2134265-2017-08477
    Event Type
    Injury
    Date Received
    August 31, 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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: THAMTORAWAT, SOMRACH ET AL. ¿INCIDENCE OF COMPLICATION AND TUMOR RECURRENCE AFTER RADIOFREQUENCY ABLATION IN HIGH-RISK LOCATION OF HEPATOCELLULAR CARCINOMA PATIENTS.¿ J MED ASSOC THAI 2014; 97 (1): 95-100. HTTP://WWW.JMATONLINE.COM. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, 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 PATIENTS EXPERIENCED COMPLICATIONS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. EARLY COMPLICATIONS OCCURRED WITHIN 30 DAYS AFTER RFA PROCEDURE WERE REPORTED AS SUBCAPSULAR HEMORRHAGE AND COLONIC INJURY. LATE COMPLICATIONS OCCURRED AFTER 30 DAYS INCLUDING HEPATIC INFARCTION AND MILD FOCAL INTRAHEPATIC DUCT DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615642 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001262230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other