BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23272921 · Received October 10, 2025

    Report

    Report Number
    3027664504-2025-00026
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 9, 2025
    Report Date
    April 3, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962006
    PMA / PMN Number
    K233466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE. AT THE REQUEST OF THE FACILITY, HISTOSONICS CONDUCTED AN EVALUATION OF THE EDISON SYSTEM USED DURING THIS CASE. SYSTEM DATA WAS OBTAINED WITH (B)(6) PERMISSION ON SEPTEMBER 26, 2025, AND A DETAILED REVIEW OF THE DEVICE (SYSTEM) DATA FROM BOTH THE SYSTEM CONFIGURATION AND SYSTEM LOG FILES WAS CONDUCTED. THIS REVIEW DETERMINED THAT THE SYSTEM WAS CONFIGURED PROPERLY AND PERFORMED AS DESIGNED/INTENDED, WITH NO UNEXPECTED ANOMALIES, FAULTS, AND/OR EVENTS. THE SYSTEM LOG FILES CONTAIN FULL EVENT DATA THROUGHOUT THE USE OF THE SYSTEM AND THE WORKFLOW AND INCLUDE TIME STAMPS OF ALL ACTIONS/EVENTS. THESE INCLUDE A TIMELINE OF EACH STEP/EVENT FOR THE PROCEDURE AND PARAMETER VALUES FOR THE PLANNED TREATMENT VOLUME (PTV) DIMENSIONS (TARGET AND MARGIN), PTV VOLUME, DEPTH, IN-VIVO CALIBRATION VOLTAGES, PLANNING PULSES VOLTAGES, AND AVERAGE AUTOMATED TREATMENT VOLTAGE AND TIME. IN SUMMARY, THREE TREATMENTS WERE PRESCRIBED AND EXECUTED. A FOURTH TREATMENT WAS PLANNED BUT WAS NOT COMPLETED. THE SYSTEM DID NOT RECORD ANY UNEXPECTED SYSTEM ERRORS, FAULTS, AND/OR ERRONEOUS EVENTS, AND FUNCTIONED AS INTENDED/DESIGNED. ALL THERAPY WAS DELIVERED WITHIN THE PHYSICIAN PRESCRIBED PLANNED TREATMENT VOLUMES WITH NO ANOMALOUS OR UNPLANNED ENERGY DELIVERY.

    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 73 YEAR OLD FEMALE PATIENT WITH A HISTORY OF NEUROENDOCRINE TUMORS WITH METASTASIS TO THE LIVER WAS TREATED WITH HISTOTRIPSY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND INCLUDED TREATMENT TO TWO LESIONS (SEGMENTS IV AND VI) AND WAS COMPRISED OF THREE HISTOTRIPSY PLANNED TREATMENT VOLUMES (PTVS) FOR A TOTAL DELIVERED TREATMENT VOLUME OF APPROXIMATELY 69CC. AS A NOTE, TWO OF THE PTVS INCLUDED PARTIALLY OVERLAPPING TREATMENTS TO ENABLE COVERAGE ON A LARGER LESION (E.G., ESTIMATED 55CC OF LESION/LIVER TISSUE TREATED BASED ON OVER-LAP). CONTRAST ENHANCED ULTRASOUND (CEUS) AND CEUS MICROBUBBLE CONTRAST AGENT WAS UTILIZED DURING THE PLANNING STAGE OF THE WORKFLOW AND PRIOR TO THERAPY EMISSION. POST-CONTRAST ENHANCED ULTRASOUND SHOWED POSSIBLE RESIDUAL FLOW WITHIN THE TREATED VOLUME ON COLOR DOPPLER, INDICATIVE OF PATENT VESSELS IN THE HISTOTRIPSY TREATMENT VOLUME. POST-PROCEDURE, THE PATIENT DEVELOPED OLIGURIA/ANURIA, RISING CREATININE, AND SIGNIFICANT PAIN AND WAS ULTIMATELY ADMITTED TO ICU ON THE DAY OF THE PROCEDURE. CONTRAST-ENHANCED CT WAS PERFORMED DUE TO CONCERN FOR BLEEDING. NO EVIDENCE OF VASCULITIS OR VASCULOPATHY AND THE VESSELS APPEARED NORMAL ON IMAGING. THE PATIENT DECOMPENSATED AND CODED ON (B)(6). CT ANGIOGRAPHY REVEALED INTRA-ABDOMINAL HEMORRHAGE WITH 5-6 HEPATIC ARTERIAL PSEUDOANEURYSMS. EMERGENT EMBOLIZATION WAS PERFORMED TO EMBOLIZE THE INVOLVED BRANCHES AND BLEEDING CONTROL WAS ACHIEVED. EMERGENT EMBOLIZATION WAS PERFORMED TO EMBOLIZE THE INVOLVED BRANCHES AND BLEEDING CONTROL WAS ACHIEVED. AS OF (B)(6), PATIENT IS OUT OF ICU, STABLE WITH LOWERED CREATINE LEVELS, MAKING URINE, AND RECEIVING SUPPORTIVE CARE INCLUDING DIALYSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 73 YEAR OLD FEMALE PATIENT WITH A HISTORY OF NEUROENDOCRINE TUMORS WITH METASTASIS TO THE LIVER WAS TREATED WITH HISTOTRIPSY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND INCLUDED TREATMENT TO TWO LESIONS (SEGMENTS IV AND VI) AND WAS COMPRISED OF THREE HISTOTRIPSY PLANNED TREATMENT VOLUMES (PTVS) FOR A TOTAL DELIVERED TREATMENT VOLUME OF APPROXIMATELY 69CC. AS A NOTE, TWO OF THE PTVS INCLUDED PARTIALLY OVERLAPPING TREATMENTS TO ENABLE COVERAGE ON A LARGER LESION (E.G., ESTIMATED 55CC OF LESION/LIVER TISSUE TREATED BASED ON OVER-LAP). CONTRAST ENHANCED ULTRASOUND (CEUS) AND CEUS MICROBUBBLE CONTRAST AGENT WAS UTILIZED DURING THE PLANNING STAGE OF THE WORKFLOW AND PRIOR TO THERAPY EMISSION. POST-CONTRAST ENHANCED ULTRASOUND SHOWED POSSIBLE RESIDUAL FLOW WITHIN THE TREATED VOLUME ON COLOR DOPPLER, INDICATIVE OF PATENT VESSELS IN THE HISTOTRIPSY TREATMENT VOLUME. POST-PROCEDURE, THE PATIENT DEVELOPED OLIGURIA/ANURIA, RISING CREATININE, AND SIGNIFICANT PAIN AND WAS ULTIMATELY ADMITTED TO ICU ON THE DAY OF THE PROCEDURE. CONTRAST-ENHANCED CT WAS PERFORMED DUE TO CONCERN FOR BLEEDING. NO EVIDENCE OF VASCULITIS OR VASCULOPATHY AND THE VESSELS APPEARED NORMAL ON IMAGING. THE PATIENT DECOMPENSATED AND CODED ON (B)(6). CT ANGIOGRAPHY REVEALED INTRA-ABDOMINAL HEMORRHAGE WITH 5-6 HEPATIC ARTERIAL PSEUDOANEURYSMS. EMERGENT EMBOLIZATION WAS PERFORMED TO EMBOLIZE THE INVOLVED BRANCHES AND BLEEDING CONTROL WAS ACHIEVED. AS OF (B)(6), PATIENT IS OUT OF ICU, STABLE WITH LOWERED CREATINE LEVELS, MAKING URINE, AND RECEIVING SUPPORTIVE CARE INCLUDING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470617 EDISON FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION QGM HISTOSONICS, INC. 00850006962006

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R