BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON

    MDR report key: 23157729 · Received September 26, 2025

    Report

    Report Number
    3027664504-2025-00024
    Event Type
    Death
    Date Received
    September 26, 2025
    Date of Event
    September 24, 2025
    Report Date
    April 6, 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.

    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 71-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEPATOCELLULAR CARCINOMA RECEIVED HISTOTRIPSY TREATMENT TO TWO LESIONS ON SEGMENT V OF THE LIVER, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 24.6 CC. A BLEED WAS NOTICED DURING POST IMAGING VIA CT WITH CONTRAST. THE PATIENT WAS MOVED TO ANOTHER OPERATING ROOM TO EMBOLIZE THE BLEED. PER ANOTHER TREATING PHYSICIAN, THE PATIENT IS STABILIZED BUT HAS NOT FULLY RECOVERED. ANGIOGRAPHY REVEALED FINDINGS SUGGESTIVE OF UNDERLYING VASCULITIS.

    Description of Event or Problem · 0

    THROUGH A PUBLISHED JOURNAL ARTICLE (BREUER J, ET AL. VASCULAR INJURY AFTER HISTOTRIPSY: A CASE SERIES OF HEMORRHAGE AND PSEUDOANEURYSM COMPLICATIONS IN HUMAN PATIENTS JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2026; 37) THE MANUFACTURER BECAME AWARE OF THE SUBSEQUENT CLINICAL COURSE AND OUTCOME OF THE PREVIOUSLY REPORTED PATIENT. FOLLOWING THE REPORTED POST-PROCEDURAL HEMORRHAGE REQUIRING EMBOLIZATION, THE PATIENT DEVELOPED HEMORRHAGIC SHOCK AND SUBSEQUENT HEPATIC DECOMPENSATION, PROGRESSING TO FULMINANT HEPATIC FAILURE. DESPITE INTENSIVE CARE MANAGEMENT, THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND EXPIRED ON POST-PROCEDURE DAY 28. HISTOSONICS IS REPORTING THIS FOLLOW UP DUE TO PROXIMITY TO PROCEDURE (WITHIN 30-DAYS). OF NOTE, THE MANUSCRIPT PROVIDED ADDITIONAL INFORMATION INCLUDING: THE PATIENT "HAD METABOLIC ASSOCIATED STEATOHEPATITIS (MELD 27, CHILD-PUGH B, ECOG 2) AND TYPE 2 DIABETES LISTED FOR ORTHOTOPIC LIVER TRANSPLANTATION, PRESENTED WITH A NEW LR-5 SEGMENT 5 OBSERVATION. THE PATIENT DECLINED LOCOREGIONAL THERAPY BUT REPEAT 3-MONTH IMAGING DEMONSTRATED INTERVAL GROWTH. BIOPSY CONFIRMED HEPATOCELLULAR CARCINOMA. AFTER HOSPITALIZATION FOR DECOMPENSATION, HISTOTRIPSY WAS OFFERED AS THE LEAST INVASIVE TREATMENT OPTION." OF NOTE, PER THE TREATING PHYSICIAN, THE HISTOTRIPSY TREATMENT VOLUME INCLUDED THE TUMOR THAT WAS RECENTLY BIOPSIED SUGGESTING A POSSIBLE COMPROMISE OF THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113067 EDISON FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R