BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 12425518 · Received September 3, 2021

    Report

    Report Number
    1717344-2021-01222
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    February 16, 2021
    Report Date
    September 3, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: THERMAL ABLATION ALONE VS THERMAL ABLATION COMBINED WITH TRANSARTERIAL CHEMOEMBOLIZATION FOR PATIENTS WITH SMALL (<(><<)>3 CM) HEPATOCELLULAR CARCINOMA. SOURCE: CLINICAL IMAGING 76 (2021) 123¿129 ACCEPTED 30 JANUARY 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE TIME TO TUMOR PROGRESSION (TTP) AND OVERALL SURVIVAL (OS) FOR PATIENTS WHO RECEIVED THERMAL ABLATION (TA) ALONE OR TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PLUS TA FOR HEPATOCELLULAR CARCINOMA. BETWEEN 2010 TO 2018, 85 TOTAL PATIENTS INCLUDED: TA ALONE 64; TACE PLUS TA 21. COOLTIP AND LEVEEN WERE BOTH USED FOR RFA AND NEUWAVE WAS USED FOR MWA. PROCEDURAL COMPLICATIONS IN THE TA GROUP INCLUDE HEMORRHAGE (2), PNEUMOTHORAX (1), AND HEMOPERITONEUM (1). POST PROCEDURAL COMPLICATIONS IN THE TACE PLUS TA GROUP INCLUDE ACCESS SITE HEMATOMA (1) AND SUBCAPSULAR HEMATOMA (1). IT IS UNKNOWN IF THESE COMPLICATIONS ARE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317717 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other