BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECTRODE

    MDR report key: 13951503 · Received March 30, 2022

    Report

    Report Number
    1717344-2022-00377
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 3, 2018
    Report Date
    March 30, 2022
    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 · 0

    TITLE: COMBINED CHEMOEMBOLIZATION AND THERMAL ABLATION FOR THE TREATMENT OF METASTASES TO THE LIVER SOURCE: ABDOM RADIOL (2018) 43:2859¿2867 PUBLISHED ONLINE: 3 MARCH 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, THE PURPOSE OF THE STUDY WAS TO EVALUATE SAFETY, TIME TO RECURRENCE, AND OVERALL SURVIVAL IN PATIENTS WITH LIVER METASTASES, TREATED WITH TRANSARTERIAL CHEMOEMBOLIZATION (TACE) FOLLOWED BY ABLATION FROM AUGUST 1998 TO SEPTEMBER 2015. THEY USED MULTIPLE ABLATION TECHNIQUES AND DEVICES WHEREIN ONE OF WHICH, INCLUDED RADIO FREQUENCY ABLATION SYSTEM WITH COOL-TIP. THERE WERE 42 PATIENTS TREATED FOR 44 LIVER METASTASES. COMPLICATIONS OCCURRED IN 19 PATIENTS (45%). MAJOR COMPLICATIONS OCCURRED IN 19% OF PATIENTS AND INCLUDED 2 PATIENTS WERE HOSPITALIZED FOR FEVER (GRADE C), 3 PATIENTS HAD HEPATIC ABSCESS AND 1 PATIENT FOR EACH OF THE FOLLOWING COMPLICATIONS: FALL REQUIRING TRANSFUSION, PORTAL VEIN THROMBUS CAUSING LOBAR INFARCT, BILIARY FISTULA, AND RETROPERITONEAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2903278 UNKNOWN COOL TIP ELECTRODE GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H