BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON SYSTEM

    MDR report key: 19886406 · Received August 1, 2024

    Report

    Report Number
    3027664504-2024-00002
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 1, 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 MALE PATIENT, (AGE 57) WITH MULTIPLE NEUROENDOCRINE METASTASES RECEIVED MULTIPLE HISTOTRIPSY TREATMENTS OF 7 LIVER TUMORS FOR A TOTAL TREATMENT VOLUME OF 90.6 CC. AS PART OF STANDARD OF CARE FOLLOWING HISTOTRIPSY AT THIS INSTITUTION, THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. THE FOLLOWING MORNING (B)(6) 2024 AS PART OF ROUTINE LAB WORK, IT WAS DETERMINED THE PATIENT HAD ELEVATED CREATININE LEVELS WHICH INDICATED ACUTE RENAL FAILURE. THE PATIENT REMAINED HOSPITALIZED AND KIDNEY CREATININE LEVELS CONTINUED TO NORMALIZE AFTER RECEIVING DIALYSIS TO NORMALIZE ELECTROLYTES. THE PATIENT HAD BEEN ON TARGETED THERAPY (CABOZANTINIB) A WEEK PRIOR TO HISTOTRIPSY. THE PATIENT WAS DISCHARGED ON (B)(6) 2024 STABLE WITH KIDNEY FUNCTION NORMALIZING BUT NOT WITHIN NORMAL LIMITS. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913613 EDISON SYSTEM Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R