BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 20046441 · Received August 23, 2024

    Report

    Report Number
    1717344-2024-01658
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    June 16, 2024
    Report Date
    August 29, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DR. (B)(6). SAFETY OF PROPOFOL SEDATION ADMINISTERED BY INTERVENTIONAL RADIOLOGISTS FOR RADIOFREQUENCY ABLATION IN PATIENTS WITH HEPATOCELLULAR CARCINOMA, 2024, JAPANESE JOURNAL OF RADIOLOGY HTTPS://DOI.ORG/10.1007/S11604-024-01615-2. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6 (RFR: (B)(4)) ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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, DURING ABLATION PROCEDURE, A RETROSPECTIVE STUDY EVALUATED THE SAFETY OF PROPOFOL SEDATION ADMINISTERED BY INTERVENTIONAL RADIOLOGISTS DURING RFA FOR HEPATOCELLULAR CARCINOMA (HCC). BETWEEN AUGUST 2018 AND DECEMBER 2020, 73 PATIENTS UNDERWENT COOL TIP RFA FOR HCC. THE FOLLOWING ABLATION RELATED ADVERSE EVENTS WERE REPORTED: LIVER ABSCESS (1), INTRABDOMINAL ABSCESS (1), AND PNEUMOTHORAX (1). SAFETY OF PROPOFOL SEDATION ADMINISTERED BY INTERVENTIONAL RADIOLOGISTS FOR RADIOFREQUENCY ABLATION IN PATIENTS WITH HEPATOCELLULAR CARCINOMA, SHINTARO KIMURA, JAPANESE JOURNAL OF RADIOLOGY.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, DURING ABLATION PROCEDURE, A RETROSPECTIVE STUDY EVALUATED THE SAFETY OF PROPOFOL SEDATION ADMINISTERED BY INTERVENTIONAL RADIOLOGISTS DURING RFA FOR HEPATOCELLULAR CARCINOMA (HCC). BETWEEN (B)(6) 2018 AND (B)(6) 2020, (B)(4) PATIENTS UNDERWENT COOL TIP RFA FOR HCC. THE FOLLOWING ABLATION RELATED ADVERSE EVENTS WERE REPORTED: LIVER ABSCESS (1), INTRABDOMINAL ABSCESS (1), AND PNEUMOTHORAX (1). ADDITIONAL INFORMATION RECEIVED ADVERSE EVENTS WERE PROCEDURE RELATED AND NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364116 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other