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	04/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 44-year-old male patient with a history of uveal melanoma metastatic to the liver received histotripsy treatment to two right hepatic tumors in segment 6, with the larger tumor requiring an overlapping treatment.No immediate procedural complications were reported.Immediate post-histotripsy ultrasound demonstrated a heterogeneous appearance of the treated lesions, and the main portal vein was documented as patent.On (b)(6), the patient presented to the emergency department after a syncopal episode, with worsening right-sided abdominal pain, lightheadedness, nausea, and urinary retention following the histotripsy procedure, resulting in admission.Initial evaluation documented symptomatic anemia and concern for liver hemorrhage.Ct abdomen/pelvis with iv contrast demonstrated a large hepatic and perihepatic hematoma, believed to be likely from a hyperattenuating lesion in the right hepatic lobe, with moderate-volume blood products along the right paracolic gutter and extending into the pelvis.Imaging also noted two scattered foci of hyperdense contrast consistent with active hemorrhage, though no large branch-vessel extravasation was identified.During admission, the patient's hemoglobin decreased from 11.0 g/dl to 8.2 g/dl.The bleeding event was managed via observation/monitoring, intravenous fluids, and the patient received 2 units of packed red blood cells via transfusion.The clinical treating team documented acute blood loss anemia due to liver hemorrhage, with a transfusion threshold to keep hemoglobin greater than 8 g/dl.The syncope was attributed to hypovolemia from liver hemorrhage.Interventional radiology was consulted for management of the hemorrhage.The patient underwent hepatic angiography and gelfoam embolization to a branch vessel within the histotripsy treatment cavity.Following embolization and transfusion, the patient's pain was controlled, hemoglobin stabilized, and he remained hemodynamically stable upon discharge on (b)(6).
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.In response to reports of vascular related complications, histosonics has incorporated the following warning into its labeling: "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
• MDR Report Key: 25306386
• Report Number: 3027664504-2026-00019
• Device Sequence Number: 9362200
• 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: K241902
• 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): 05/27/2026

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: 04/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male