BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON

    MDR report key: 25322385 · Received May 28, 2026

    Report

    Report Number
    3027664504-2026-00021
    Event Type
    Death
    Date Received
    May 28, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 28, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS WERE REPORTED TO HAVE OCCURRED DURING THE HISTOTRIPSY PROCEDURE. HISTOSONICS IS SUBMITTING THIS REPORT BECAUSE THE DEATH OCCURRED WITHIN 30 DAYS OF TREATMENT AND THE TREATING PHYSICIAN'S ASSESSMENT OF THE EVENT BEING "POSSIBLY RELATED" TO THE HISTOTRIPSY PROCEDURE AND DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, AS PART OF THE BOOMBOX POST-MARKET CLINICAL STUDY, A 65-YEAR-OLD MALE PATIENT WITH METASTATIC PANCREATIC ADENOCARCINOMA UNDERWENT HISTOTRIPSY TREATMENT TO FOUR LIVER LESIONS LOCATED IN SEGMENTS II, III, VI, AND VII, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 102.5 CC. THE CLINICAL STUDY SITE RECEIVED POST-MORTEM NOTIFICATION THROUGH THE EMR NOTING THAT THE PATIENT PASSED AWAY AT HOME ON (B)(6). THE DEATH NOTIFICATION DOCUMENTED THAT THE PATIENT HAD A 15-MONTH HISTORY OF METASTATIC PANCREATIC CANCER AND PASSED AWAY AT HOME WITH FAMILY PRESENT. PER THE TREATING PHYSICIAN, THE PATIENT WAS IN A CLINICALLY DIFFICULT SITUATION WITH PROGRESSIVE MALIGNANCY AND POSSIBLE CHRONIC LIVER FAILURE. THE PHYSICIAN NOTED THAT THE PATIENT'S DEATH MAY HAVE BEEN CAUSED BY PROGRESSION OF DISEASE AND/OR UNDERLYING LIVER DISEASE. HOWEVER, BECAUSE THE DEATH OCCURRED WITHIN 30 DAYS OF THE INTERVENTION, THE PHYSICIAN WAS UNABLE TO DEFINITIVELY ATTRIBUTE THE DEATH SOLELY TO THE PATIENT'S CHRONIC DISEASE OR TO THE INTERVENTION. THEREFORE, THE EVENT WAS ASSESSED AS "POSSIBLY RELATED" TO THE HISTOTRIPSY TREATMENT PROCEDURE AND "POSSIBLY RELATED" TO THE HISTOSONICS HISTOTRIPSY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301074 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death