BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 19868227 · Received July 30, 2024

    Report

    Report Number
    3021325287-2024-00005
    Event Type
    Death
    Date Received
    July 30, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 30, 2024
    Manufacturer
    NOAH MEDICAL INC.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, DURING A NOAH GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, A PATIENT EXPERIENCED EXCESSIVE BLEEDING, CARDIAC ARREST, AND ULTIMATELY, DEATH. AFTER BIOPSIES WERE COMPLETED, THE PHYSICIAN ATTEMPTED TO RETRACT THE SCOPE TO END THE BRONCHOSCOPY PROCEDURE, AND WHEN THE SCOPE WAS ALMOST TAKEN OUT, THE CRNA NOTICED A LARGE AMOUNT OF BLOOD IN THE ENDOTRACHEAL TUBE. IN RESPONSE, THE PHYSICIAN ADMINISTERED COLD SALINE, EPINEPHRINE, AND TRANEXAMIC ACID TO CONTROL THE BLEEDING. DESPITE THESE INTERVENTIONS, THE PATIENT WENT INTO CARDIAC ARREST AND IMMEDIATELY STAFF PERFORMED CHEST COMPRESSIONS. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE. IT IS IMPORTANT TO NOTE THAT NO MALFUNCTIONS OF THE NOAH GALAXY DEVICE WERE REPORTED DURING THE PROCEDURE. ADDITIONALLY, THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE USE OF THE GALAXY DEVICE. THE PHYSICIAN SUSPECTS THE PATIENT'S DEATH WAS POSSIBLY DUE TO TAKING PRESCRIBED BLOOD THINNERS AND BLOOD VESSEL NOT BEING VISIBLE, LEADING TO PUNCTURE BY BIOPSY FORCEPS. THE SCOPE HAS BEEN RETURNED TO NOAH MEDICAL FOR EVALUATION AND THE SCOPE PERFORMED AS EXPECTED WITHOUT ANY MALFUNCTIONS. INVESTIGATION INDICATES THAT THE GALAXY SYSTEM PERFORMED AS EXPECTED, WITH NO ISSUES OBSERVED IN THE PROCEDURE RECORDING. BLEEDING WAS VISIBLE ON CAMERA AND FLUOROSCOPIC VISUALIZATION, AND THE SYSTEM PROVIDED SUFFICIENT INFORMATION FOR THE USER TO MAKE INFORMED DECISIONS ABOUT NECESSARY ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE SCOPE AFTER PERFORMING MULTIPLE BIOPSIES WHEN THE STAFF NOTICED BLOOD IN THE ET TUBE. THE PATIENT THEN WENT INTO CARDIAC ARREST AND, DESPITE INTERVENTIONS, EVENTUALLY PASSED AWAY. NO MALFUNCTIONS OF THE NOAH GALAXY DEVICE WERE REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253666 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL INC. 2024060502

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death