BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON

    MDR report key: 25163151 · Received May 13, 2026

    Report

    Report Number
    3027664504-2026-00017
    Event Type
    Death
    Date Received
    May 13, 2026
    Date of Event
    October 27, 2025
    Report Date
    May 13, 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

    SIX OF THE AKIS NOTED IN THE ABSTRACT MET THE CRITERIA FOR MDR REPORTABILITY - THE GRADE 1 AND 2 AKIS WERE, BY DEFINITION, NON-SERIOUS AND DID NOT REQUIRE INTERVENTION. FOUR OF THOSE SIX HAD BEEN KNOWN TO HISTOSONICS AND WERE PREVIOUSLY REPORTED TO FDA. THIS REPORT IS TO PROVIDE INFORMATION ON THE TWO REPORTED AKIS NOT PREVIOUSLY KNOWN TO HISTOSONICS. ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION ABOUT THE INCIDENTS WHICH HAD NOT BEEN PREVIOUSLY KNOWN TO HISTOSONICS, HOWEVER NO ADDITIONAL INFORMATION WAS RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, AN UPDATE WILL BE MADE TO THIS REPORT. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE HISTOTRIPSY PROCEDURE. THE RELATIONSHIP OF THE AKI AND DEATH TO HISTOTRIPSY IS INDETERMINATE BASED ON THE AVAILABLE INFORMATION, GIVEN SIGNIFICANT BASELINE RENAL IMPAIRMENT, URETERAL OBSTRUCTION, PROGRESSIVE METASTATIC DISEASE, AND OTHER COMPETING CLINICAL FACTORS. IN RESPONSE TO REPORTS OF ACUTE KIDNEY INJURY ASSOCIATED WITH HISTOTRIPSY, HISTOSONICS HAS INCORPORATED THE FOLLOWING WARNING INTO ITS LABELING: "CONSIDER PATIENT SPECIFIC RISK FACTORS FOR ACUTE KIDNEY INJURY (AKI) AND/OR RENAL FAILURE BASED ON CLINICAL HISTORY AND PROCEDURAL SCENARIOS THAT COULD INCREASE STRESS ON KIDNEY FUNCTION, INCLUDING BUT NOT LIMITED TO HYDRATION STATUS, PLANNED TREATMENT VOLUME AND EXPECTED USE OF IMAGING CONTRAST AGENTS. CONSISTENT WITH OTHER LIVER-DIRECTED THERAPIES, TREATMENTS INVOLVING LARGE TREATMENT VOLUMES OR MULTIPLE TREATMENT SESSIONS MAY BE ASSOCIATED WITH AN INCREASED RISK OF AKI. EVALUATE RENAL RISK AND MONITOR FOR SIGNS OF AKI BEFORE AND AFTER TREATMENT."

    Description of Event or Problem · 0

    HISTOSONICS WAS MADE AWARE OF AN ABSTRACT PRESENTED AT THE SOCIETY OF INTERVENTIONAL RADIOLOGY MEETING ON APRIL 13, 2026 (POE ET AL. HISTOTRIPSY-INDUCED ACUTE KIDNEY INJURY FOLLOWING LIVER TUMOR TREATMENT: A PRELIMINARY REPORT OF 8 CASES. SIR 2026 INTERVENTIONAL ONCOLOGY) WHICH DESCRIBES EIGHT (8) PATIENTS EXPERIENCING ACUTE KIDNEY INJURY (AKI) POST-HISTOTRIPSY (SIX GRADE 3, ONE GRADE 2 AND ONE GRADE 1), AND INCLUDED TWO PATIENT DEATHS WITHOUT DETAILS ON THE TIMING OF THOSE DEATHS IN RELATION TO THE HISTOTRIPSY PROCEDURE. THE INTENT OF THIS REPORT IS TO COVER THE PREVIOUSLY UNREPORTED INCIDENTS. ADDITIONAL INFORMATION REGARDING ONE OF THE PATIENTS INCLUDED IN THIS ABSTRACT WAS PROVIDED BY THE TREATING PHYSICIAN: ON (B)(6) 2025, A 66-YEAR-OLD FEMALE WITH METASTATIC ENDOMETRIAL CARCINOSARCOMA AND BASELINE RENAL DYSFUNCTION UNDERWENT HISTOTRIPSY TREATMENT TO ONE LIVER LESION IN SEGMENT V FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 33.5 CC. THE PATIENT PREVIOUSLY HAD SURGERY AND MULTIPLE LINES OF THERAPY. SHE TOLERATED THE HISTOTRIPSY PROCEDURE WITHOUT IMMEDIATE COMPLICATION, AND RECEIVED ONE (1) LITER OF IV FLUIDS OVER THE COURSE OF THE 4 HOUR PROCEDURE. THE PATIENT HAD ELEVATED CREATININE PRIOR TO TREATMENT, WHICH CONTINUED TO RISE, INCREASING FROM 2.33 MG/DL ON (B)(6) TO 2.70 MG/DL ON (B)(6) AND 4.04 MG/DL ON (B)(6), WITH EGFR DECLINING TO APPROXIMATELY 12 ML/MIN/1.73 M². THE PATIENT WAS ADMITTED ON (B)(6) FOR WORSENING RENAL FUNCTION AND REQUIRED DIALYSIS. NEPHROLOGY AT THE TREATING FACILITY ASSESSED THE AKI AS MULTIFACTORIAL, WITH POSSIBLE CONTRIBUTORS INCLUDING HYPOVOLEMIA/POOR ORAL INTAKE, ACUTE TUBULAR NECROSIS, AND POSTRENAL OBSTRUCTION RELATED TO MALIGNANCY OR URETERAL OBSTRUCTION. THE PATIENT SUBSEQUENTLY DEVELOPED MULTI-ORGAN FAILURE AND DIED ON OCTOBER 27TH, 40 DAYS POST-HISTOTRIPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437534 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| O| D