BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON

    MDR report key: 23802548 · Received December 15, 2025

    Report

    Report Number
    3027664504-2025-00039
    Event Type
    Death
    Date Received
    December 15, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 15, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962006
    PMA / PMN Number
    K233466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 57 YEAR OLD MALE WITH EXTENSIVE TUMOR BURDEN (APPROXIMATELY 50% OF LIVER VOLUME) AND A HISTORY OF ACINAR PANCREATIC CANCER WITH METASTASIS TO THE LIVER RECEIVED THREE OVERLAPPING HISTOTRIPSY TREATMENTS TO A LARGE LIVER TUMOR INVOLVING SEGMENT 5 AND A SINGLE TREATMENT TO LIVER SEGMENT 3, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 127.34CC. PER THE TREATING PHYSICIAN, THE PATIENT HAD PRIOR EXTERNAL BEAM RADIATION THERAPY AND Y90, WHICH OVERLAPPED WITH THE HISTOTRIPSY TREATMENT. TWO MONTHS PRIOR, THE PATIENT HAD HISTOTRIPSY TO THREE TUMORS AND TOLERATED THE TREATMENT WELL. DURING THE THIRD HISTOTRIPSY SESSION, THE FOLEY CATHETER OUTPUT APPEARED BLOODY, AND THE PATIENT BECAME HYPOTENSIVE. THE ANESTHESIA TEAM INTERVENED AND INITIALLY APPROVED CONTINUATION OF THE PROCEDURE; HOWEVER, TREATMENT WAS PAUSED AGAIN WHEN THE URINE COLOR CHANGED SIGNIFICANTLY. THE CASE WAS ABORTED AFTER THE FOURTH TREATMENT TO SEGMENT 3. IV FLUIDS WERE STARTED AT THE END OF THE PROCEDURE. IN THE RECOVERY ROOM, THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT AND PAIN, AND IV PAIN MEDICATION WAS ADMINISTERED. THE TREATING PHYSICIAN NOTIFIED THE ON-CALL TEAM ABOUT THE CASE AND WAS LATER INFORMED THAT THE PATIENT HAD CODED, WAS SUBSEQUENTLY STABILIZED AND ADMITTED TO THE ICU FOR OBSERVATION. SUBSEQUENT IMAGING REVEALED A HEMOPERITONEUM BUT NO CLEAR SOURCE OF THE BLEEDING WAS IDENTIFIED. THE TREATING PHYSICIAN HYPOTHESIZED THAT THE SOURCE OF THE BLEED COULD BE A POTENTIAL TUMOR RUPTURE. LABORATORY EVALUATION REVEALED AN INTERNATIONAL NORMALIZED RATIO OF 16, WHICH DECREASED TO 2 BY THE FOLLOWING MORNING. VASOPRESSORS WERE DISCONTINUED AFTER STABILIZATION AND PATIENT WAS GIVEN A TRANSFUSION. THE PATIENT CODED AGAIN ON (B)(6) AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272903 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962006

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| D