BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 9840723 · Received March 17, 2020

    Report

    Report Number
    1717344-2020-00302
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    January 1, 2018
    Report Date
    April 9, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE FEASIBILITY, SAFETY, AND LONG-TERM EFFICACY OF STEREOSTATIC RADIOFREQUENCY ABLATION FOR TUMORS ADJACENT TO THE DIAPHRAGM IN THE HEPATIC DOME: A CASE-CONTROL STUDY SOURCE EUROPEAN RADIOLOGY, VOLUME 30, 2020 (950-960) DATE OF PUBLICATION ONLINE: 5 SEPTEMBER 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY PERFORMED, 891 CONSECUTIVE PATIENTS WERE TREATED BY STEREOTACTIC RF ABLATION (SRFA). A TOTAL OF 177 OF THESE PATIENTS WITH HEPATIC DOME TUMORS WERE SELECTED BY USING A NEAREST NEIGHBOR PROPENSITY SCORE FOR THIS RETROSPECTIVE STUDY. A MEDIAN OF 2 TUMORS (1¿11) WERE TREATED PER ABLATION SESSION (IN TOTAL 204 SESSIONS), INCLUDING 111 PATIENTS (62.7%) WITH ADDITIONAL TUMORS OUTSIDE OF THE HEPATIC DOME. THE TOTAL MAJOR COMPLICATION RATE WAS 12.3% (25 OF 204). OUT OF 177 PATIENTS, 2 CASES HAD THERMAL INJURIES OF THE DIAPHRAGM LEAD TO A LOCAL DEFECT THAT HAD TO BE SURGICALLY REPAIRED, 1 PATIENT HAD DEVELOPED LIVER FAILURE AFTER TREATMENT OF 2 HCCS (5CM AND 3CM) REQUIRING SALVAGE LIVER TRANSPLANTATION, 1 CASE HAD THERMAL INJURY OF THE BOWEL THAT HAD TO BE REPAIRED SURGICALLY. THIS COMPLICATION WAS RELATED TO SIMULTANEOUS THERMAL ABLATION OF AN ADDITIONAL TUMOR IN SEGMENT VI IN THE SAME SESSION. 1 PATIENT HAD TRANSIENT PULMONARY FAILURE WITH BILATERAL EFFUSIONS, 5 PATIENTS HAD PLEURAL EFFUSIONS REQUIRING THORACENTESES. A TOTAL OF 14/25 (56%) MAJOR COMPLICATIONS WERE SUCCESSFULLY TREATED BY THE INTERVENTIONAL RADIOLOGIST IN THE SAME ANESTHESIA SESSION BY PLACING A THORACOSTOMY TUBE IN 5 PATIENTS WITH PNEUMOTHORACES AND BY TRANSARTERIAL EMBOLIZATION IN NINE PATIENTS WITH HEPATIC HEMORRHAGES, RESPECTIVELY. ¿SRFA WAS SUCCESSFULLY COMPLETED ACCORDING TO PLAN IN ALL 238 TUMORS (TECHNICAL SUCCESS RATE 100%).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304844 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other