BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23878765 · Received December 23, 2025

    Report

    Report Number
    3027664504-2025-00043
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE. IN RESPONSE TO REPORTS OF ACUTE KIDNEY INJURY ASSOCIATED WITH HISTOTRIPSY, HISTOSONICS HAS INCORPORATED THE FOLLOWING WARNING INTO ITS LABELING: "AS REPORTED IN OTHER LIVER DIRECTED THERAPIES, MULTIPLE OR LARGE-VOLUME LIVER TREATMENTS HAVE BEEN ASSOCIATED WITH ACUTE KIDNEY INJURY (AKI). WHEN PLANNING EXTENSIVE OR MULTIPLE TREATMENTS, EVALUATE AND MONITOR THE PATIENT FOR SIGNS OF AKI."

    Description of Event or Problem · 0

    ON (B)(6) 2025 A 62-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER RECEIVED TWO OVERLAPPING HISTOTRIPSY TREATMENTS TO A SINGLE TUMOR, IN LIVER SEGMENT III FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 29.2 CC. THE HISTOTRIPSY TREATMENT WAS IN THE AFTERNOON; THE PATIENT WAS NPO (INSTRUCTED NOT TO EAT OR DRINK) FROM MIDNIGHT THE NIGHT BEFORE. 5,000 UNITS OF HEPARIN WAS ADMINISTERED JUST PRIOR TO HISTOTRIPSY TREATMENT. DURING THE PROCEDURE, THE PATIENT RECEIVED 600 CC OF IV FLUIDS. THE HISTOTRIPSY TREATMENT WAS COMPLETED WITHOUT COMPLICATION. FOLLOWING TREATMENT, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY (AKI) AND IS NOW ON DIALYSIS. AS OF DECEMBER 15TH, KIDNEY FUNCTION IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800863 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R