BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 12853310 · Received November 22, 2021

    Report

    Report Number
    3014447948-2021-00028
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 26, 2021
    Report Date
    October 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT UPPER LOBE. IN ADDITION TO THE PNEUMOTHORAX, THE PATIENT SUFFERED AN ALLERGIC REACTION TO ANESTHETIC. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748979 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H AURIS - BIOPSY FORCEPS| MEDTRONIC ARCPOINT NEEDLE| MEDTRONIC RADIAL| MONARCH BRONCHOSCOPE