BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIDENT

    MDR report key: 8245919 · Received January 14, 2019

    Report

    Report Number
    1717344-2019-00087
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    June 25, 2016
    Report Date
    January 14, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    UDI-DI
    10884524001579
    PMA / PMN Number
    K011676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE MWA VERSUS RFA FOR PERIVASCULAR AND PERIBILIARY CRLM: A RETROSPECTIVE PATIENT- AND LESION-BASED ANALYSIS OF TWO HISTORICAL COHORTS SOURCE CARDIOVASC INTERVENT RADIOL. 39 (9) (1438¿1446), 2016. DATE OF PUBLICATION: 25 JUN 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 25 JUNE 2016,THIS IS A RETROSPECTIVE STUDY TO ANALYZE THE SAFETY AND EFFICACY OF RADIOFREQUENCY ABLATION (RFA) VERSUS MICROWAVE ABLATION (MWA) IN THE TREATMENT OF UNRESECTABLE COLORECTAL LIVER METASTASES (CRLM) IN PROXIMITY TO LARGE VESSELS AND/ OR MAJOR BILE DUCTS. FOR MWA, THEY USED 3.7- CM MICROWAVE ANTENNA(S) (EVIDENT, COVIDIEN, DUBLIN, IRELAND). COMPLICATIONS FOR PATIENTS WITH MWA WERE AS FOLLOWS: RELATED TO PROBE INJURY AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: PNEUMOTHORAX, HEPATIC HEMORRHAGE; RELATED TO THERMAL INJURY AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: FEVER, PAIN AND FEVER, SUBPHRENICAL ABSCESS, BILIARY OBSTRUCTION, AND BILIOPLEURAL FISTULA; RELATED TO THE GENERAL PROCEDURE AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: URINARY TRACT INFECTION, PLEXUS BRACHIALIS NEURALGIA, AND BENIGN CARDIAC ARRYTHMIA; AND RELATED TO THERMAL INJURY AND OCCURRING IN 6.2% (2/32 LESIONS): BILOMA/BILIARY LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39235 EVIDENT SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER VTGEN 10884524001579

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR