BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23707693 · Received December 3, 2025

    Report

    Report Number
    3027664504-2025-00034
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    December 15, 2025
    Report Date
    March 27, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962006
    PMA / PMN Number
    K233466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE. THE TREATING PHYSICIAN DEEMED THIS SUBSEQUENT ADVERSE EVENT TO BE DEVICE AND PROCEDURE RELATED.

    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

    AS PART OF ONGOING SEQUALAE RELATIVE TO HISTOTRIPSY TREATMENT, THE PATIENT DEVELOPED A BILE LEAK AND SUBSEQUENTLY REQUIRED BILIARY STENT PLACEMENT FOR MANAGEMENT AS WELL AS HOSPITALIZATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, AS PART OF THE BOOMBOX CLINICAL STUDY, A 33 YEAR OLD FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER WITH METASTASES TO THE LIVER RECEIVED HISTOTRIPSY TREATMENT TO 2.5 CM LESION IN LIVER SEGMENT IV FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 22.4 CC. THE PROCEDURE INVOLVED TWO OVERLAPPING PTVS TO ACHIEVE FULL TUMOR COVERAGE. THE TUMOR WAS ABUTTING THE LEFT PORTAL VEIN AND BILE DUCT. HEPARIN WAS ADMINISTERED IMMEDIATELY PRIOR TO EACH TREATMENT. THE PATIENT HAD PREVIOUSLY UNDERGONE A RIGHT HEPATECTOMY. NO COMORBIDITIES WERE PRESENT, AND RENAL FUNCTION WAS NORMAL PRIOR TO TREATMENT. POST-PROCEDURE, THE PATIENT EXPERIENCED BLEEDING INTO THE TREATMENT ZONE WITH PSEUDOANEURYSM FORMATION, IDENTIFIED ON IMMEDIATE POST-OPERATIVE CT. A HEMOGLOBIN DROP WAS NOTED ON OVERNIGHT LABS. THE PATIENT RECEIVED A TRANSFUSION ON THE EVENING OF (B)(6). ALSO, ON THAT DAY SERUM CREATININE INCREASED TO 3.0 MG/DL AND CONTINUED TO RISE UNTIL DIALYSIS WAS INITIATED ON (B)(6). THE PATIENT WAS DISCHARGED ON (B)(6) AND CONTINUED OUTPATIENT DIALYSIS. AS OF (B)(6), THE PATIENT REMAINS ON DIALYSIS BUT CONTINUES TO PRODUCE URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857733 EDISON FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION QGM HISTOSONICS, INC. 00850006962006

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization| R