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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, an (b)(6) year old female with a history of breast cancer and hcc previously treated with chemotherapy and extensive radioembolization received a single histotripsy treatment to a tumor in segment iii (along the portal vein) for a total planned treatment volume (ptv) of approximately 14.1 cc.Per the treating physician, her previous radioembolizations were not directly overlapping with the histotripsy ptv.Her platelet count was stable and she was not on anti-coagulation prior to the procedure.The liver capsule was not compromised, but the histotripsy ptv did overlap the capsule.Prior to histotripsy delivery, the patient was given 3000 units of heparin.When she awoke from anesthesia, she had severe abdominal pain (more than typically observed).Abdomen was soft but tender in the treated region and ct scan showed hemoperitoneum.The bleeding appeared to extend from the site of the histotripsy treatment zone.No pseudoaneurysms were observed.She had mild hypoxia, required oxygen and received a unit of blood resulting in normalization of hemoglobin.She was discharged post-procedure day 5 without further intervention and has fully recovered.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The post-procedural intraperitoneal hemorrhage 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: 25766113
• Report Number: 3027664504-2026-00027
• Device Sequence Number: 10471582
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 06/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female