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	Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	05/25/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Although the clinical circumstances of the death are unknown, histosonics is submitting this report out of an abundance of caution due to the proximity of the histotripsy procedure to the event.
Event or Problem Description
As part of the boombox post-market clinical trial, an 85 year old female patient with a diagnosis of colorectal cancer with metastases to the liver had histotripsy on (b)(6) 2025 to a 4 cm lesion in liver segment 5 for a total planned treatment volume (ptv) of 20.9 cc.The patient was discharged the same day.The patients' daughter reported that the patient was very groggy from anesthesia, sleeping more than normal and had low blood pressure.The following day, the patient was found unresponsive and was unable to be revived.Histosonics was made aware of the event on october 9,2025.No additional case information was available.No device malfunctions or other noteworthy events were alleged to have occurred during the procedure.

• 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: 23501150
• Report Number: 3027664504-2025-00032
• Device Sequence Number: 12987840
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: 10/09/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Female