BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 15565832 · Received October 7, 2022

    Report

    Report Number
    1717344-2022-01260
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    April 9, 2022
    Report Date
    October 7, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: UNKNOWN COOL TI, UNKNOWN COOL TIP ELECRTRODE (LOT#UNKNOWN); UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA (LOT#UNKNOWN); UNKNOWN VT MWA, UNKNOWN MICROWAVE DISPOSABLE (LOT#UNKNOWN); UNKNOWN COOL TI, UNKNOWN COOL TIP ELECRTRODE (LOT#UNKNOWN); UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA (LOT#UNKNOWN); UNKNOWN VT MWA, UNKNOWN MICROWAVE DISPOSABLE (LOT#UNKNOWN); UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA (LOT#UNKNOWN); UNKNOWN VT MWA, UNKNOWN MICROWAVE DISPOSABLE (LOT#UNKNOWN) TITLE: IMPROVED OUTCOMES OF THERMAL ABLATION FOR COLORECTAL LIVER METASTASES: A 10-YEAR ANALYSIS FROM THE PROSPECTIVE AMSTERDAM CORE REGISTRY (AMCORE) SOURCE: CARDIOVASC INTERVENT RADIOL (2022) 45:1074¿1089 / PUBLISHED ONLINE: 18 MAY 2022 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY FROM JANUARY 2010 TO FEBRUARY 2021 ANALYZED OUTCOMES OF 449 PATIENTS WITH LIVER-ONLY METASTATIC COLORECTAL CARCINOMA WHO UNDERWENT OPEN OR PERCUTANEOUS THERMAL ABLATION WITH EITHER RADIOFREQUENCY ABLATION (RFA) OR MICROWAVE ABLATION (MWA). RFA WAS PERFORMED WITH EITHER THE COOL TIP RFA SYSTEM OR COMPETITOR DEVICES. MWA WAS PERFORMED WITH EITHER THE EVIDENT OR EMPRINT SYSTEM OR COMPETITOR DEVICES. USING THE CTCAE COMPLICATION GRADING SCALE, THE AUTHORS REPORTED TWENTY-EIGHT GRADE 1 AND THIRTY-EIGHT GRADE 2 COMPLICATIONS. THE AUTHORS DID NOT PROVIDE ANY DETAILS ONSPECIFIC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276001 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male