BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 20049620 · Received August 23, 2024

    Report

    Report Number
    1717344-2024-01671
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    January 12, 2024
    Report Date
    August 23, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN RF ELECTRODE (LOT#: UNKNOWN) YUETING SUN, BAOXIAN LIU, HUI SHEN, YI ZHANG, RUIYING ZHENG, JIAMING LIU, HANLIANG HU, XIAOYAN XIE, GUANGLIANG HUANG. COX MODEL RISK SCORE TO PREDICT SURVIVAL OF INTRAHEPATIC CHOLANGIOCARCINOMA AFTER ULTRASOUND-GUIDED ABLATION. ABDOMINAL RADIOLOGY (2024) 49. HTTPS://DOI.ORG/10.1007/S00261-024-04192-0. PAGES 1653¿1663. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXPLORED THE POTENTIAL FACTORS ASSOCIATE WITH OVERALL SURVIVAL (OS) AND PROGRESSION-FREE SURVIVAL (PFS) AS WELL ESTABLISHING A MODEL TO PREDICT SURVIVAL OF INTRAHEPATIC CHOLANGIOCARCINOMA (ICCA) AFTER ULTRASOUND-GUIDED THERMAL ABLATION. BETWEEN AUGUST 2008 AND OCTOBER 2022, 52 PATIENTS RECEIVED RFA ABLATION WITH THE COOL-TIP (81 LESIONS) AND MWA WITH A COMPETITOR DEVICE (5 LESIONS). THE FOLLOWING MINOR ADVERSE EVENTS WERE REPORTED WHICH RESOLVED WITHOUT INTERVENTION: PLEUR AL EFFUSION (2), NAUSEA AND VOMITING (1), LOCALIZED EFFUSION UNDER THE RIGHT SUBHEPATIC REGION (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380809 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male SEE NOTE ON H11