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	Fatigue (1849); Fever (1858); Cholangitis (4821); Hyperphosphatemia (4828); Bacteremia (4846)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.
Event or Problem Description
On (b)(6) 2026, a 60-year-old male patient, enrolled into the boombox study with a history of metastatic colorectal cancer to the liver, underwent histotripsy treatment.A single hepatic lesion was treated in segment viii.The treatment comprised two overlapping planned treatment volumes (ptvs) for a total treatment volume of approximately 67cc.The patient had prior chemotherapy, y90 radioembolization therapy to both hepatic lobes in 2023, and histotripsy to segment v/viii on (b)(6) 2026.In the interval between histotripsy treatments (b)(6), the patient underwent hepatic artery infusion (hai) pump treatment with floxuridine (fudr) therapy.The patient had continued disease progression with significant tumor burden and compromised liver function prior to the second histotripsy procedure.Post-procedurally, the patient developed fever and was admitted on (b)(6) for further evaluation.Blood cultures were positive for clostridium species, and the clinical presentation was consistent with cholangitis with associated bacteremia.Ct imaging on the day of admission showed a lesion with gas in the right side of the liver, likely related to the histotripsy treatment.It also showed thickening of the wall in the ascending colon and rectum, which was thought to be due to portal colonopathy or inflammation/infection of the colon or rectum not thought to be procedurally related.The patient was treated with intravenous antibiotics.Following discharge from hospitialization on (b)(6), the patient experienced ongoing clinical decline, including persistent weakness and elevated alkaline phosphatase levels (baseline on (b)(6) - 320 u/l; pod 14 - 965 u/l).The patient has since been taken off antibiotics, but he has not returned to his pre-procedural baseline based on information available at the time of filing.According to the treating physician, the patient's overall clinical course is confounded by progressive underlying metastatic disease with increasing tumor burden and limited remaining therapeutic options, making definitive attribution of the clinical decompensation to any single cause difficult given the multifactorial clinical context.

• 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: 24958724
• Report Number: 3027664504-2026-00014
• Device Sequence Number: 18720968
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male