BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 11719714 · Received April 23, 2021

    Report

    Report Number
    3014447948-2021-00009
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 26, 2021
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K193534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. THE RISK OF BLEEDING IS DOCUMENTED IN (B)(4), REV D, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED.

    Description of Event or Problem · 1

    ON 03/26/2021, IT WAS REPORTED THAT MAJOR BLEEDING WAS DISCOVERED IN A PATIENT SIX HOURS AFTER A MONARCH-ASSISTED BRONCHOSCOPIC PROCEDURE. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN SHOWED A LARGE RIGHT SIDED PLEURAL EFFUSION AND A DROP IN HEMOGLOBIN THAT PROMPTED A RIGHT THORACOTOMY WITH EVACUATION OF THE HEMOTHORAX AND A RIGHT UPPER LOBE WEDGE RESECTION. NO OBVIOUS SITE OF THE BLEEDING WAS FOUND INTRAOPERATIVELY. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE BLEEDING WAS THE MASS ITSELF. THE PATIENT WAS NOT ON ANTICOAGULANTS AND THE BIOPSY POSSIBLY PRECIPITATED THE BLEEDING. THIS ADVERSE EFFECT IS RELATED TO THE PROCEDURE AND IS A RECOGNIZED OUTCOME OF A BRONCHOSCOPIC GUIDED LUNG BIOPSY. CONTRIBUTING FACTORS ARE THAT THE LESION WAS FOUND TO BE ADENOCARCINOMA AND MORE PRONE TO BLEEDING THAT NORMAL LUNG TISSUE. THE PATIENT DID REQUIRE A FOUR-UNIT BLOOD TRANSFUSION AND WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615819 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R