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	Thrombosis/Thrombus (4440)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No other noteworthy events occurred during the case.Portal vein thrombosis was observed in #hope4liver trials and is disclosed as a residual risk in the device labeling.
Event or Problem Description
On (b)(6) 2025, a 72-year-old female with a history of breast cancer metastasis to the liver received histotripsy treatment to a single lesion located in liver segment i for a total planned treatment volume (ptv) of 9 cc.The procedure included three cycles through the in-vivo calibration portion of the workflow, due to treatment parameters exceeding thermal safeguards.The treating physician administered 3,000 units of heparin on two separate occasions during the histotripsy procedure due to the proximity of the targeted tumor to the hepatic vasculature.Intravenous fluids were administered throughout the procedure, and urine output was continuously monitored.The post-procedure ct demonstrated a portal vein thrombosis and a potential bleed at the treatment site with an associated hemoglobin drop of 2 g/dl.The patient remained in the hospital for two days.In addition, the patient was started on low-molecular weight heparin while in the hospital and discharged on eliquis for the portal vein thrombus.At the one-month follow-up, imaging revealed residual but improving portal vein thrombosis, and perfusion abnormalities involving the left hepatic lobe and segment iii.

• 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: 23324190
• Report Number: 3027664504-2025-00027
• Device Sequence Number: 16111631
• 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): 10/17/2025

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: 09/19/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female