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 Code	Insufficient Information (4580)
Date of Event	03/13/2026
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2026, as part of the boombox post-market clinical study, a 65-year-old male patient with metastatic pancreatic adenocarcinoma underwent histotripsy treatment to four liver lesions located in segments ii, iii, vi, and vii, for a total planned treatment volume (ptv) of approximately 102.5 cc.The clinical study site received post-mortem notification through the emr noting that the patient passed away at home on (b)(6).The death notification documented that the patient had a 15-month history of metastatic pancreatic cancer and passed away at home with family present.Per the treating physician, the patient was in a clinically difficult situation with progressive malignancy and possible chronic liver failure.The physician noted that the patient's death may have been caused by progression of disease and/or underlying liver disease.However, because the death occurred within 30 days of the intervention, the physician was unable to definitively attribute the death solely to the patient's chronic disease or to the intervention.Therefore, the event was assessed as "possibly related" to the histotripsy treatment procedure and "possibly related" to the histosonics histotripsy device.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events were reported to have occurred during the histotripsy procedure.Histosonics is submitting this report because the death occurred within 30 days of treatment and the treating physician's assessment of the event being "possibly related" to the histotripsy procedure and device.

• 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
• MDR Report Key: 25322385
• Report Number: 3027664504-2026-00021
• Device Sequence Number: 5368361
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K241902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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: Death
• Patient Age: 65 YR
• Patient Sex: Male