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	Atrial Fibrillation (1729); Hematoma (1884)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, as part of the boombox post-market clinical study, a (b)(6)-year-old female patient with metastatic breast cancer to the liver, received a histotripsy treatment to two tumors in liver segments v and viii for a total planned treatment volume (ptv) of approximately 47.6 cc.The patient was discharged prior to evaluation of the post-procedure imaging.The following morning, a nurse from the treating facility called the patient to check in and the patient reported dizziness, shortness of breath with exertion, intermittent palpitations, chest discomfort, weakness, and fatigue.The patient's spouse reported a home blood pressure of 98/53 mmhg with a heart rate of 108 bpm.The patient was directed to seek emergency evaluation and upon presentation to the emergency department (ed), they were admitted.Vital signs on admission included a blood pressure of 88/57 mmhg and pulse of 116 bpm.The post-procedure imaging indicated a subcapsular hepatic hematoma.The patient was placed on a sepsis pathway and received intravenous fluids and 500 ml of packed red blood cells the patient was discharged the same day from the ed following observation.The patient continued to experience tachycardia on (b)(6), with reported heart rates ranging from 101 to the 130s, including at rest.Due to persistent symptoms, the patient was admitted to the hospital on april 11th where an ecg evaluation identified atrial fibrillation (af), which the treating physician reported as "probable" attribution to the histotripsy procedure, as af is often related to general anesthesia.The patient was given amiodarone for arrhythmia management which normalized and the patient was discharged on (b)(6).
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The post-procedural subcapsular hepatic hematoma is consistent with the labeled risk of mechanical injury to the liver capsule when vascular structures or the liver capsule are within or adjacent to the planned treatment volume.The edison system labeling includes the following warning statement: "mechanical injury to critical structures (e.G., vascular structures, liver capsule, bile ducts) may occur when these structures are within the ptv.The likelihood of bleeding and/or mechanical injury may also increase with additional and/or subsequent treatments within a treatment session or across follow-up treatments.".

• 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: 25641994
• Report Number: 3027664504-2026-00026
• Device Sequence Number: 15834244
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 241902
• 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): 06/26/2026

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: 06/04/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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: Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female