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	Renal Impairment (4499)
Date of Event	04/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of the boombox post-market clinical study, on (b)(6) 2025, a 77 year old female patient with a history of hepatocellular carcinoma received histotripsy treatment to two lesions in liver segments vi and vii for a total planned treatment volume (ptv) of approximately 43.4 cc.As per treating facility standard of care, the patient was held overnight for observation and discharged the following day.Later that day, the patient developed red-tinged sputum with clots.The patient contacted the treating physician and was advised to present to an emergency department for evaluation.On (b)(6) the patient was admitted to a local hospital with presumptive pneumonia and acute kidney injury although creatinine values were not available (baseline or elevated).The patient remained hospitalized until transfer to the treating facility was initiated on (b)(6).The patient was evaluated by the treating physician on (b)(6).After review of the outside hospital records and imaging, the treating physician documented that the patient did not appear to have pneumonia and that the pulmonary findings were more likely atelectasis related to single-lung ventilation during the histotripsy procedure.Laboratory testing on (b)(6)showed improved renal function, with creatinine decreased to 1.78 mg/dl from a reported value greater than 3 mg/dl.The acute kidney injury was documented as significantly improved.No dialysis or renal replacement therapy was reported.The patient was discharged home on (b)(6) with follow-up arranged in clinic.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The post-procedural acute kidney injury is consistent with the labeled risk associated with large treatment volumes and multiple treatment sessions.Histosonics has incorporated the following warning into its labeling: "consider patient-specific risk factors for acute kidney injury (aki) and/or renal failure based on clinical history and procedural scenarios that may increase stress on kidney function.Factors to consider include, but are not limited to, hydration status, planned treatment volume, number of treatment sessions, use of nephrotoxic agents including nsaids, and expected use of imaging contrast agents.The risk of aki increases as total treatment volume increases.In patients with compromised pre-procedure renal function, aki may progress to acute renal failure.Renal risk should be evaluated before treatment, and renal function should be monitored for signs of aki before, during, and after treatment.".

• 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 ; +1(612)351-0361
• MDR Report Key: 50184463
• Report Number: 3027664504-2026-00033
• Device Sequence Number: 10305188
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• 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; Other
• Patient Age: 77 YR
• Patient Sex: Female