BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 24957481 · Received April 22, 2026

    Report

    Report Number
    3027664504-2026-00015
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 21, 2026
    Report Date
    April 22, 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 HISTOTRIPSY PROCEDURE. 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 51-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER WITH LIVER METASTASES UNDERWENT HISTOTRIPSY TREATMENT TO A SINGLE HEPATIC LESION IN SEGMENT V FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 33.5 CC. PATIENT WAS ON NSAIDS PRIOR TO TREATMENT AND HAD A CT SCAN WITH CONTRAST IMMEDIATELY POST PROCEDURE. THE PATIENT DEVELOPED ACUTE RENAL FAILURE, PRESENTED WITH LOWER EXTREMITY EDEMA AND WAS HYPERTENSIVE (NO PRIOR HISTORY) WHEN ADMITTED ON (B)(6). LABORATORY EVALUATION DEMONSTRATED A PEAK CREATININE OF 11 MG/DL. THE PATIENT DID NOT REQUIRE DIALYSIS. A KIDNEY BIOPSY WAS PERFORMED, WITH PATHOLOGY FINDINGS CONSISTENT WITH ACUTE INTERSTITIAL NEPHRITIS (AIN), WHICH WAS ASSESSED AS LIKELY MEDICATION-(NSAIDS) INDUCED. THE PATIENT WAS DISCHARGED ON (B)(6) AND RENAL FUNCTION SUBSEQUENTLY IMPROVED, WITH THE MOST RECENT CREATININE REPORTED AT 1.38 MG/DL ON (B)(6), AND NORMALIZED TO 0.9 AS OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54025 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other| H