BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23878763 · Received December 23, 2025

    Report

    Report Number
    3027664504-2025-00042
    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
    PA, 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 63-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF BREAST CANCER WITH METASTASES TO THE LIVER RECEIVED FIVE HISTOTRIPSY TREATMENTS TO FOUR LESIONS IN MULTIPLE SEGMENTS, FOR AN APPROXIMATE TOTAL PLANNED TREATMENT VOLUME (PTV) OF 114 CC. THE PATIENT RECEIVED 3,000 UNITS OF HEPARIN AND 5 LITERS OF INTRAVENOUS FLUIDS DURING THE PROCEDURE. POST-PROCEDURE, LABORATORY EVALUATION REVEALED A CREATININE LEVEL OF 4 MG/DL INDICATING ACUTE KIDNEY INJURY (AKI) WITH AN ELEVATION IN TOTAL BILIRUBIN TO 5 MG/DL. THE PATIENT WAS ADMITTED LATER THAT EVENING FOR FURTHER MANAGEMENT, WITH CONTINUED INTRAVENOUS FLUID RESUSCITATION. THE PATIENT WAS DISCHARGED BUT CONTINUED ON INTERMITTENT HEMODIALYSIS. HEPATIC FUNCTION HAS RECOVERED AND RETURNED TO PATIENT'S BASELINE. RENAL FUNCTION IS IMPROVING, WITH CREATININE DECREASED FROM 7.0 TO 3.0 MG/DL. THE PATIENT CONTINUES TO PRODUCE URINE, WITH ONGOING RENAL RECOVERY AND REMAINS ON A HEMODIALYSIS AS OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919691 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| R