BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON

    MDR report key: 23840381 · Received December 18, 2025

    Report

    Report Number
    3027664504-2025-00041
    Event Type
    Death
    Date Received
    December 18, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 18, 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 MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE. IN RESPONSE TO REPORTS OF ACUTE KIDNEY INJURY ASSOCIATED WITH HISTOTRIPSY, HISTOSONICS HAS INCORPORATED THE FOLLOWING WARNING INTO ITS LABELING: "AS REPORTED IN OTHER LIVERDIRECTED THERAPIES, MULTIPLE OR LARGE-VOLUME LIVER TREATMENTS HAVE BEEN ASSOCIATED WITH ACUTE KIDNEY INJURY (AKI). WHEN PLANNING EXTENSIVE OR MULTIPLE TREATMENTS, EVALUATE AND MONITOR THE PATIENT FOR SIGNS OF AKI."

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 76-YEAR-OLD FEMALE WITH A HISTORY OF METASTATIC SIGMOID COLON CANCER WITH HEPATIC METASTASES RECEIVED HISTOTRIPSY TO LIVER TUMORS IN SEGMENTS 4 AND 6 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 101.1CC. THE PATIENTS' COURSE WAS COMPLICATED BY POST-PROCEDURAL HEMORRHAGE FROM A RUPTURED METASTATIC LIVER TUMOR IN SEGMENT 4B THAT HAD BEEN TREATED WITH HISTOTRIPSY, CONFIRMED BY CLINICAL DETERIORATION, LABORATORY EVIDENCE OF ACUTE BLOOD LOSS ANEMIA, AND IMAGING VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) THAT IDENTIFIED ACTIVE ARTERIAL BLEEDING FROM THE LEFT HEPATIC LOBE. THE PATIENT UNDERWENT EMBOLIZATION OF A SUBSEGMENTAL INFERIOR LEFT HEPATIC ARTERY BRANCH. THE PATIENT REQUIRED A TRANSFUSION OF PACKED RED BLOOD CELLS AND PLATELETS FOR ACUTE BLOOD LOSS ANEMIA, WITH SERIAL LABORATORY MONITORING TO GUIDE FURTHER TRANSFUSION NEEDS. THE PATIENTS' POST-OPERATIVE COURSE WAS FURTHER COMPLICATED BY ACUTE KIDNEY INJURY (AKI), ATTRIBUTED TO ACUTE TUBULAR NECROSIS BASED ON URINE SEDIMENT AND RISING CREATININE. HER BLOOD PRESSURE WAS PERSISTENTLY ELEVATED AND MANAGED WITH AMLODIPINE. THE PATIENT ALSO EXPERIENCED SIGNIFICANT ELEVATIONS IN LIVER FUNCTION TESTS (LFTS) AND BILIRUBIN; HER LIVER FUNCTION SHOWED PERIODS OF IMPROVEMENT AND SUBSEQUENT UP TRENDING OF BILIRUBIN AND TRANSAMINASES. THE PATIENT REMAINED HOSPITALIZED, WITH SEVERE HYPERBILIRUBINEMIA, AND PERSISTENT AKI AND ULTIMATELY PASSED AWAY ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386812 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H| D