BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 24958724 · Received April 22, 2026

    Report

    Report Number
    3027664504-2026-00014
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 22, 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

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE HISTOTRIPSY PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A 60-YEAR-OLD MALE PATIENT, ENROLLED INTO THE BOOMBOX STUDY WITH A HISTORY OF METASTATIC COLORECTAL CANCER TO THE LIVER, UNDERWENT HISTOTRIPSY TREATMENT. A SINGLE HEPATIC LESION WAS TREATED IN SEGMENT VIII. THE TREATMENT COMPRISED TWO OVERLAPPING PLANNED TREATMENT VOLUMES (PTVS) FOR A TOTAL TREATMENT VOLUME OF APPROXIMATELY 67CC. THE PATIENT HAD PRIOR CHEMOTHERAPY, Y90 RADIOEMBOLIZATION THERAPY TO BOTH HEPATIC LOBES IN 2023, AND HISTOTRIPSY TO SEGMENT V/VIII ON (B)(6) 2026. IN THE INTERVAL BETWEEN HISTOTRIPSY TREATMENTS (B)(6), THE PATIENT UNDERWENT HEPATIC ARTERY INFUSION (HAI) PUMP TREATMENT WITH FLOXURIDINE (FUDR) THERAPY. THE PATIENT HAD CONTINUED DISEASE PROGRESSION WITH SIGNIFICANT TUMOR BURDEN AND COMPROMISED LIVER FUNCTION PRIOR TO THE SECOND HISTOTRIPSY PROCEDURE. POST-PROCEDURALLY, THE PATIENT DEVELOPED FEVER AND WAS ADMITTED ON (B)(6) FOR FURTHER EVALUATION. BLOOD CULTURES WERE POSITIVE FOR CLOSTRIDIUM SPECIES, AND THE CLINICAL PRESENTATION WAS CONSISTENT WITH CHOLANGITIS WITH ASSOCIATED BACTEREMIA. CT IMAGING ON THE DAY OF ADMISSION SHOWED A LESION WITH GAS IN THE RIGHT SIDE OF THE LIVER, LIKELY RELATED TO THE HISTOTRIPSY TREATMENT. IT ALSO SHOWED THICKENING OF THE WALL IN THE ASCENDING COLON AND RECTUM, WHICH WAS THOUGHT TO BE DUE TO PORTAL COLONOPATHY OR INFLAMMATION/INFECTION OF THE COLON OR RECTUM NOT THOUGHT TO BE PROCEDURALLY RELATED. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. FOLLOWING DISCHARGE FROM HOSPITIALIZATION ON (B)(6), THE PATIENT EXPERIENCED ONGOING CLINICAL DECLINE, INCLUDING PERSISTENT WEAKNESS AND ELEVATED ALKALINE PHOSPHATASE LEVELS (BASELINE ON (B)(6) - 320 U/L; POD 14 - 965 U/L). THE PATIENT HAS SINCE BEEN TAKEN OFF ANTIBIOTICS, BUT HE HAS NOT RETURNED TO HIS PRE-PROCEDURAL BASELINE BASED ON INFORMATION AVAILABLE AT THE TIME OF FILING. ACCORDING TO THE TREATING PHYSICIAN, THE PATIENT'S OVERALL CLINICAL COURSE IS CONFOUNDED BY PROGRESSIVE UNDERLYING METASTATIC DISEASE WITH INCREASING TUMOR BURDEN AND LIMITED REMAINING THERAPEUTIC OPTIONS, MAKING DEFINITIVE ATTRIBUTION OF THE CLINICAL DECOMPENSATION TO ANY SINGLE CAUSE DIFFICULT GIVEN THE MULTIFACTORIAL CLINICAL CONTEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53371 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H