BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON SYSTEM

    MDR report key: 19887434 · Received August 1, 2024

    Report

    Report Number
    3027664504-2024-00003
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 1, 2024
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    PMA / PMN Number
    DEN220087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS REPORTED BY THE USER.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A FEMALE PATIENT, (AGE 61) WITH MULTIPLE NEUROENDOCRINE METASTASES RECEIVED MULTIPLE HISTOTRIPSY TREATMENTS FOR 9 LIVER TUMORS, FOR A TOTAL TREATMENT VOLUME OF 109.6 CC. AS PART OF STANDARD OF CARE FOLLOWING HISTOTRIPSY AT THIS INSTITUTION, THE PATIENT WAS ADMITTED PRIOR TO THE PROCEDURE. THROUGHOUT THE CASE, CONTINUOUS BLOOD PRESSURE MONITORING WAS PERFORMED AND THERE WERE NO OBVIOUS CAUSES OR INCIDENCE OF PROLONGED HEMODYNAMIC INSTABILITY. HOWEVER, TOWARDS THE END OF THE CASE, THE PATIENT SUDDENLY STOPPED MAKING URINE. IMMEDIATELY AFTER THE PROCEDURE, ELEVATED LEVELS OF CHROMOGRANIN (BLOOD MARKER) WERE OBSERVED. THE PATIENT HAD TROUBLE WAKING UP FROM ANESTHESIA AND NEEDED TO BE RE-INTUBATED, WHICH RESULTED IN THE PATIENT BEING ADMITTED TO THE ICU. THE PATIENT RECEIVED FLUID REPLACEMENT TO ADDRESS RENAL IMPAIRMENT AND STABILIZED. THE PATIENT HAD BEEN ON TARGETED THERAPY (CABOZANTINIB) WHICH WAS STOPPED ONE MONTH PRIOR TO HISTOTRIPSY. THE PATIENT WAS DISCHARGED ON (B)(6) 2024 AND KIDNEY FUNCTION HAS RETURNED TO NORMAL LEVELS. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957963 EDISON SYSTEM Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R