BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP

    MDR report key: 8410363 · Received March 11, 2019

    Report

    Report Number
    1717344-2019-00312
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    October 19, 2018
    Report Date
    March 11, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524001210
    PMA / PMN Number
    K973297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE ASSESSMENT OF RADIOFREQUENCY ABLATION EFFICACY FOR HEPATOCELLULAR CARCINOMA BY HISTOLOGY AND PRETRANSPLANT RADIOLOGY SOURCE LIVER TRANSPLANTATION, VOLUME 25, 2019 (88-97) ARTICLE NUMBER: 1 DATE OF PUBLICATION: 19 OCTOBER 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED JANUARY 2007 TO DECEMBER 2016, THIS STUDY AIMED AT EVALUATING THE HISTOLOGIC RESPONSE AFTER RFA OF SMALL HCCS ARISING IN CIRRHOSIS. DATA WERE REVIEWED FROM 78 PATIENTS WITH DE NOVO EARLY-STAGE HEPATOCELLULAR CARCINOMA (HCCS) WHO WERE TREATED WITH RFA AND SUBSEQUENTLY TRANSPLANTED. PERCUTANEOUS RFA WAS PERFORMED USING A COOL-TIP SINGLE NEEDLE (COOL-TIP RADIOFREQUENCY ELECTRODE; RADIONICS, MINNEAPOLIS, USA) HAVING A LENGTH OF 20 CM WITH AN EXPOSED TIP OF 2 OR 3 CM. THE LENGTH OF THE EXPOSED TIP USED DEPENDED ON THE TUMOR DIMENSIONS. THE TOTAL NUMBER OF RFA SESSIONS WAS 92. DURING THESE SESSIONS, 14 PATIENTS HAD SOME COMPLICATIONS FOR A TOTAL OF 18 (19.6%) EVENTS, BUT ONLY 1 INFECTIOUS COMPLICATION GRADED AS 3 (DEFINABLE AS MAJOR) OCCURRED, RETURNING A MAJOR COMPLICATION RATE OF ONLY 1.1%. DETAILS ARE REPORTED IN TABLE 4; GRADE 1-2 PLEURAL EFFUSION= 3. NOTABLY, MOST OF THE COMPLICATIONS WERE GRADED AS MINOR, AND MORBIDITY IN ABLATED PATIENTS HAVING THE LARGEST TUMOR >3 CM WAS SIGNIFICANTLY HIGHER (35.0%) THAN THAT OF PATIENTS HAVING THE LARGEST TREATED TUMOR =3 CM (9.7%; P = 0.01). NO NEEDLE TRACT SEEDING AMONG 125 TREATED NODULES WAS DETECTED. AUTHORS NOTED THAT THE DATA DEMONSTRATE THE SAFETY OF THE ABLATIVE PROCEDURE AND ARE IN KEEPING WITH THE LITERATURE, AND EVEN IN SOME INSTANCES, LOWER THAN THE REPORTED MORBIDITY. PLEASE REFER TO THE ATTACHED FULL TEXT FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202230 COOL-TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER ACT2020 10884524001210

    Patients

    Seq Age Sex Outcome Treatment
    1