BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDISON SYSTEM

    MDR report key: 22006894 · Received May 12, 2025

    Report

    Report Number
    3027664504-2025-00007
    Event Type
    Death
    Date Received
    May 12, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 12, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962006
    PMA / PMN Number
    K233466
    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.

    Description of Event or Problem · 0

    A 81-YEAR-OLD MALE PATIENT WITH ADVANCED METASTATIC CHOLANGIOCARCINOMA RECEIVED REPEAT HISTOTRIPSY TREATMENT (INITIAL TREATMENT (B)(6) 2025, TOTAL PTV 49.0 CC) ON (B)(6) 2025, TO A SINGLE LESION IN SEGMENT V, WITH TWO PARTIALLY OVERLAPPING PLANNED TREATMENT VOLUMES (PTVS) REPORTED AS PTV 1: TOTAL PTV = 31 CC, PTV 2: TOTAL PTV = 29.5CC, FOR A TOTAL PTV OF 60.5 CC. THE PATIENT WAS DISCHARGED POST-PROCEDURE WITHOUT INCIDENT AND ULTIMATELY RETURNED HOME. ON POST-OPERATIVE DAY 3 ((B)(6) 2025), HE DEVELOPED ANURIA, AND HIS CREATININE ROSE TO 7. THE TREATING PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT HEMODIALYSIS AND HAD SOME URINE OUTPUT, WITH A DIAGNOSIS OF ACUTE TUBULAR NECROSIS (ATN) ATTRIBUTED TO A COMBINATION OF ANESTHESIA, HISTOTRIPSY, AND NSAID USE, WITH POSSIBLE CONTRIBUTION FROM ACUTE INTERSTITIAL NEPHRITIS (AIN). THE PATIENT REMAINED DIALYSIS-DEPENDENT, BUT ON-GOING HYPOTENSION COMPLICATED MANAGEMENT. THE FAMILY ULTIMATELY ELECTED TO WITHDRAW CARE AND THE PATIENT DIED ON (B)(6) 2025. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368482 EDISON SYSTEM Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962006

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| D| H