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	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.In response to reports of acute kidney injury associated with histotripsy, 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 could increase stress on kidney function, including but not limited to hydration status, planned treatment volume and expected use of imaging contrast agents.Consistent with other liver-directed therapies, treatments involving large treatment volumes or multiple treatment sessions may be associated with an increased risk of aki.Evaluate renal risk and monitor for signs of aki before and after treatment.".
Event or Problem Description
As part of the boombox clinical study, a 54-year-old male patient with a history of metastatic colon cancer received histotripsy treatment to three tumors in segments 3, 4, and 6, with a total planned treatment volume (ptv) of approximately 53.7 cc on (b)(6) 2026.Iv contrast ct scan following histotripsy showed adequate tumor coverage with histotripsy with no other findings.The patient presented to the emergency department around midnight the same day with pain, nausea, and emesis.A second ct scan with contrast was ordered (approximately six hours after the prior contrast study).The patient's creatinine was elevated to 2.4 mg/dl just prior to the ct scan.Following the second ct with iv contrast, the patient's creatinine increased to 5.29 mg/dl.The patient was hospitalized for six days and was medically managed and monitored.Renal function subsequently improved without the need for dialysis.At discharge, creatinine decreased to 2.7 mg/dl.

• 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: 25306554
• Report Number: 3027664504-2026-00020
• Device Sequence Number: 9422830
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,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: 04/30/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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; Other
• Patient Age: 54 YR
• Patient Sex: Male