BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS COUNTRY ACCESS TOOL

    MDR report key: 11900943 · Received May 28, 2021

    Report

    Report Number
    3004962788-2021-00049
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    February 9, 2021
    Report Date
    May 28, 2021
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    EOQ
    UDI-DI
    10884521539723
    PMA / PMN Number
    K142934
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: TRANSBRONCHIAL MICROWAVE ABLATION OF LUNG NODULES WITH ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY GUIDANCE¿A NOVEL TECHNIQUE AND INITIAL EXPERIENCE WITH 30 CASES. SOURCE: TRANSL LUNG CANCER RES 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, THIS STUDY AIMED TO ASSESS THE OUTCOME OF TRANSBRONCHIAL MICROWAVE ABLATION OF LUNG NODULES WITH ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY GUIDANCE. TOTAL OF 30 LUNG NODULES FROM 25 PATIENTS WERE TREATED. MILD IMMEDIATE OR DELAYED PLEURITIC CHEST PAIN WAS PRESENT IN 4 CASES (13.3%) AND RESPONDED TO COMMON ORAL ANALGESICS AND DID NOT PROLONG HOSPITAL STAY. ALL 4 OF THE LESIONS WERE CLOSE TO PLEURA, AND THE MECHANISM OF PAIN COULD BE DUE TO PLEURAL IRRITATION AFTER ABLATION OF PERIPHERALLY LOCATED LUNG NODULES. NO REFERRED PAIN TO SHOULDER DUE TO PHRENIC NERVE INJURY, OR REFERRED PAIN TO ARM DUE TO BRACHIAL PLEXUS INJURY OCCURRED. PNEUMOTHORAX OCCURRED IN 2 CASES (6.67%) AND BOTH REQUIRED CHEST DRAIN INSERTION. POST ABLATION REACTION INCLUDING FEVER OCCURRED IN 2 CASES (6.67%); WHILE MILD HEMOPTYSIS WAS NOTED IN 1 CASE (3.33%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797033 CROSS COUNTRY ACCESS TOOL BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ COVIDIEN LP - SUPERDIMENSION INC SDATSW01 10884521539723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other