BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 22755069 · Received August 8, 2025

    Report

    Report Number
    3027664504-2025-00016
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 8, 2025
    Manufacturer
    HISTOSONICS, INC
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE PATIENT WITH A METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) OF THE LIVER RECEIVED HISTOTRIPSY TREATMENT(S) TO LIVER SEGMENTS VI AND VIII ON (B)(6) 2025. THE TOTAL HISTOTRIPSY PLANNED TREATMENT VOLUME (PTV) WAS 57.7 CC. AS A NOTE, THE PATIENT PREVIOUSLY HAD HISTOTRIPSY IN (B)(6) 2025 TO LIVER SEGMENTS II AND IV. THE PATIENT RECEIVED ANTICOAGULATION THERAPY, APIXABAN (ELIQUIS, 5 MG), POST-PROCEDURE. THE FOLLOWING MORNING (B)(6), THE PATIENT DEVELOPED SEVERE, ACUTE ABDOMINAL PAIN. LABORATORY TESTING REVEALED A HEMOGLOBIN DROP FROM 9.2 G/DL (IMMEDIATELY POSTOPERATIVELY) TO 7.2 G/DL. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED ACTIVE BLEEDING (CONTRAST EXTRAVASATION) FROM THE RIGHT POSTERIOR HEPATIC LOBE ADJACENT TO THE AREA TREATED IN SEGMENTS VI AND VIII. ANTI-COAGULATION WAS REVERSED WITH FOUR-FACTOR PROTHROMBIN COMPLEX CONCENTRATE (KCENTRA), WITH HEMOGLOBIN DROPPING TO 6.6 G/DL BEFORE STABILIZING. INTERVENTIONAL RADIOLOGY WAS CONSULTED BUT DEFERRED EMBOLIZATION DUE TO THE PATIENT'S HEMODYNAMIC STABILITY. THE PATIENT WAS SUPPORTED WITH RED BLOOD CELL TRANSFUSIONS (THREE UNITS) THROUGHOUT THE DAY AND EVENING. ON (B)(6), HEMOGLOBIN REMAINED REFRACTORY TO TRANSFUSION. REPEAT CTA DEMONSTRATED ONGOING BLEEDING ADJACENT TO THE TREATMENT AREA. THE PATIENT UNDERWENT GELFOAM EMBOLIZATION OF A BRANCH OF THE RIGHT HEPATIC ARTERY. FOLLOWING THE PROCEDURE, THE PATIENT SHOWED CLINICAL IMPROVEMENT AND WAS DISCHARGED HOME ON (B)(6). NO OTHER DOWNSTREAM CLINICAL SEQUELAE HAVE BEEN REPORTED TO DATE. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065513 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R