BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 13366157 · Received January 27, 2022

    Report

    Report Number
    1717344-2022-00100
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    June 5, 2021
    Report Date
    January 27, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: FEASIBILITY, SAFETY, AND EFCACY OF ARTIFICIAL CARBON DIOXIDE PNEUMOTHORAX FOR COMPUTED TOMOGRAPHY FLUOROSCOPY-GUIDED PERCUTANEOUS RADIOFREQUENCY ABLATION OF HEPATOCELLULAR CARCINOMA SOURCE: JAPANESE JOURNAL OF RADIOLOGY (2021) 39:1119¿1126 HTTPS://DOI.ORG/10.1007/S11604-021-01148-Y. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED OUTCOMES OF 24 PATIENTS WHO UNDERWENT ARTIFICIAL CO2 PNEUMOTHORAX FOR CT FLUOROSCOPY-GUIDED PERCUTANEOUS RF ABLATION OF HEPATOCELLULAR CARCINOMA (HCC) BETWEEN APRIL 2011 AND DECEMBER 2017. THE RF ABLATION WAS PERFORMED USING A 17-GAUGE INTERNALLY COOLED ELECTRODE WITH A 2- OR 3-CM EXPOSED TIP (COOL-TIP RF ABLATION SYSTEM). REPORTED COMPLICATIONS INCLUDED INTRA-ABDOMINAL HEMORRHAGE IN TWO CASES. INTERVENTIONS WERE NOT SPECIFIED BUT COMPLICATIONS LISTED AS ¿MINOR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811284 UNKNOWN COOL TIP ELECRTRODE GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other