MAUDE Adverse Event Report: HISTOSONICS, INC. EDISON; Focused ultrasound system for non-thermal, mechanical tissue ablation

Catalog Number	EDNTC1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Hematuria (2558); Intra-Abdominal Hemorrhage (4479)
Date of Event	11/19/2025
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2025, a 57 year old male with extensive tumor burden (approximately 50% of liver volume) and a history of acinar pancreatic cancer with metastasis to the liver received three overlapping histotripsy treatments to a large liver tumor involving segment 5 and a single treatment to liver segment 3, for a total planned treatment volume (ptv) of 127.34cc.Per the treating physician, the patient had prior external beam radiation therapy and y90, which overlapped with the histotripsy treatment.Two months prior, the patient had histotripsy to three tumors and tolerated the treatment well.During the third histotripsy session, the foley catheter output appeared bloody, and the patient became hypotensive.The anesthesia team intervened and initially approved continuation of the procedure; however, treatment was paused again when the urine color changed significantly.The case was aborted after the fourth treatment to segment 3.Iv fluids were started at the end of the procedure.In the recovery room, the patient experienced abdominal discomfort and pain, and iv pain medication was administered.The treating physician notified the on-call team about the case and was later informed that the patient had coded, was subsequently stabilized and admitted to the icu for observation.Subsequent imaging revealed a hemoperitoneum but no clear source of the bleeding was identified.The treating physician hypothesized that the source of the bleed could be a potential tumor rupture.Laboratory evaluation revealed an international normalized ratio of 16, which decreased to 2 by the following morning.Vasopressors were discontinued after stabilization and patient was given a transfusion.The patient coded again on (b)(6) and passed away.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the case.

• Brand Name: EDISON
• Common Device Name: Focused ultrasound system for non-thermal, mechanical tissue ablation
• Manufacturer (Section D): HISTOSONICS, INC.; 16305 36th avenue n; suite 300; plymouth MN 55446
• Manufacturer (Section G): HISTOSONICS, INC; 16305 36th avenue n; suite 300; plymouth MN 55446
• Manufacturer Contact: leeanne swiridow ; 16305 36th avenue n; suite 300; plymouth, MN 55446 ; 6123510361
• MDR Report Key: 23802548
• Report Number: 3027664504-2025-00039
• Device Sequence Number: 9297317
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EDNTC1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 57 YR
• Patient Sex: Male