BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23383545 · Received October 24, 2025

    Report

    Report Number
    3027664504-2025-00031
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 24, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, AN 84-YEAR-OLD MALE PATIENT WITH A HISTORY OF HEPATOCELLULAR CHOLANGIOCARCINOMA RECEIVED TWO OVERLAPPING HISTOTRIPSY TREATMENTS TO A SINGLE LESION WHICH HAD BEEN PREVIOUSLY TREATED WITH Y90. THE TOTAL PLANNED TREATMENT VOLUME (PTV) WAS 43.8 CC. ON THE DAY OF THE HISTOTRIPSY PROCEDURE, THE PATIENT'S PLATELET COUNT WAS 44 ×10^9/L, AND A PLATELET TRANSFUSION WAS ADMINISTERED IMMEDIATELY PRIOR TO THE PROCEDURE. POST PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DEMONSTRATED AN ACTIVE BLEED FROM THE LESION. THE PATIENT WAS TAKEN FOR ANGIOGRAM WITH EMBOLIZATION OF THE TUMORAL VESSEL. THE PATIENT STAYED IN ICU THE NIGHT OF TREATMENT FOR OBSERVATION WITH STABLE HEMOGLOBIN. PATIENT WAS CALLED ON (B)(6) AND IS DOING WELL. ONE-MONTH FOLLOW UP MRI IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703587 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention