BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23324148 · Received October 17, 2025

    Report

    Report Number
    3027664504-2025-00029
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 17, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 LIVER-DIRECTED 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 59 YEAR OLD FEMALE PATIENT WITH A HISTORY OF WELL-DIFFERENTIATED GRADE 2 NEUROENDOCRINE TUMOR METASTATIC TO LIVER RECEIVED HISTOTRIPSY TREATMENT WHICH CONSISTED OF TWO OVERLAPPING PLANNED TREATMENT VOLUMES (PTV) OF 33.5 ML FOR A TOTAL ESTIMATED TREATMENT VOLUME OF 55 ML FOR A 4 CM LESION. THE PATIENT RECEIVED APPROXIMATELY 3 LITERS OF LACTATED RINGER'S SOLUTION DURING AND IMMEDIATELY FOLLOWING THE PROCEDURE. THE FOLEY CATHETER INITIALLY DRAINED CLEAR YELLOW URINE; HOWEVER, URINE OUTPUT PLATEAUED AT 200-300 ML DURING THE LATTER HALF OF THE TREATMENT. AT THE CONCLUSION OF THE PROCEDURE, "MUCUS-LIKE MATERIAL" WAS OBSERVED WITHIN THE FOLEY TUBING, THOUGH URINE REMAINED YELLOW THROUGHOUT. WITHIN 1-2 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED TEA-COLORED URINE WHILE THE FOLEY REMAINED IN PLACE. OLIGURIA WAS NOTED LATER THAT EVENING, PROMPTING HOSPITAL ADMISSION. NEPHROLOGY WAS CONSULTED, AND AN ADDITIONAL LITER OF NORMAL SALINE WAS ADMINISTERED. BLOOD UREA NITROGEN (BUN) AND SERUM CREATININE BEGAN RISING THE FOLLOWING MORNING, WHILE SODIUM AND POTASSIUM LEVELS REMAINED WITHIN NORMAL LIMITS. OVER THE SUBSEQUENT 10 DAYS, BUN AND CREATININE CONTINUED TO INCREASE, PEAKING AT 92 AND 13.5 MG/DL RESPECTIVELY, NECESSITATING A 10-DAY HOSPITALIZATION. DESPITE PERSISTENT OLIGURIA EARLY ON, URINE OUTPUT GRADUALLY IMPROVED OVER THIS PERIOD. DIALYSIS WAS NOT REQUIRED. NEPHROLOGY FOLLOWED THE PATIENT DAILY, AND SEVERAL INTERMITTENT DOSES OF BUMETANIDE WERE ADMINISTERED FOR SUBCLINICAL PULMONARY EDEMA, EVIDENCED BY CRACKLES ON LUNG EXAMINATION WITHOUT DYSPNEA. RENAL FUNCTION IS NOW RECOVERING, WITH MOST RECENT LABORATORY VALUES ON (B)(6) 2025 SHOWING CREATININE AT 1.16 MG/DL AND BUN AT 19 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820322 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention