BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 24714804 · Received March 30, 2026

    Report

    Report Number
    3027664504-2026-00010
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 27, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: "CONSIDER PATIENT-SPECIFIC RISK FACTORS FOR ACUTE KIDNEY INJURY (AKI) AND/OR RENAL FAILURE BASED ON CLINICAL HISTORY AND PROCEDURAL SCENARIOS THAT COULD INCREASE STRESS ON KIDNEY FUNCTION, INCLUDING BUT NOT LIMITED TO HYDRATION STATUS, PLANNED TREATMENT VOLUME AND EXPECTED USE OF IMAGING CONTRAST AGENTS. CONSISTENT WITH OTHER LIVER-DIRECTED THERAPIES, TREATMENTS INVOLVING LARGE TREATMENT VOLUMES OR MULTIPLE TREATMENT SESSIONS MAY BE ASSOCIATED WITH AN INCREASED RISK OF AKI. EVALUATE RENAL RISK AND MONITOR FOR SIGNS OF AKI BEFORE AND AFTER TREATMENT."

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT WITH A HISTORY OF NEUROENDOCRINE TUMOR (NET) RECEIVED HISTOTRIPSY TREATMENT TO TWO HEPATIC TUMORS IN SEGMENTS II AND III FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 43.3 CC. NO HEMATURIA WAS OBSERVED DURING THE PROCEDURE. THE PATIENT HAD NO REPORTED PRIOR HISTORY OF RENAL DISEASE OR KNOWN RENAL RISK FACTORS. ON THE DAY OF THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE ACUTE KIDNEY INJURY (AKI) AND WAS ADMITTED FOR INPATIENT MANAGEMENT. THE PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY ONE WEEK. DURING HOSPITALIZATION, THE PATIENT REQUIRED TWO SESSIONS OF DIALYSIS, AFTER WHICH RENAL FUNCTION IMPROVED, AND THE AKI RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777749 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R