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	Ascites (2596); Abdominal Distention (2601); Hyponatremia (4494); Renal Impairment (4499)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction was reported.In response to reports of acute kidney injury associated with histotripsy, histosonics has incorporated the following warning into its labeling: "as reported in other liver-directed therapies, multiple or large-volume liver treatments have been associated with acute kidney injury (aki).When planning extensive or multiple treatments, evaluate and monitor the patient for signs of aki.".
Event or Problem Description
On (b)(6) 2025, a 64-year-old female with a diagnosis of colorectal cancer metastatic to the liver underwent histotripsy treatment to five separate targets involving segments 2/3, 4a/b, and 7, for a total ptv of ~161 cm3.The procedure was completed without intraoperative complications.Post-procedure, both ultrasound and ct imaging revealed unremarkable findings with no evidence of procedural complications.However, the patient developed a transient acute kidney injury (aki), with serum creatinine rising from 47.9 mol/l pre-treatment to 444 mol/l by (b)(6), subsequently normalizing by (b)(6).The nephrology team attributed the aki to the histotripsy procedure.Concurrently, the patient developed hyponatremia, with serum sodium levels dropping from normal pre-treatment values to 118 mmol/l on (b)(6) and a nadir of 116 mmol/l on (b)(6), returning to normal by (b)(6).These abnormalities were managed supportively.The patient was also noted to have abdominal distension during recovery.An ultrasound confirmed the presence of ascites.Additionally, a contrast-enhanced mri was performed one day post-treatment for further evaluation.The patient received a short steroid (predinsolone) taper post-procedure consisting of 30 mg delivered on day 1, 20 mg on day 2, and 10 mg on day 3.Following hospitalization, the patient was discharged in stable condition.Follow-up communication indicated that the patient was recovering well, with full resolution of the acute kidney injury and other post-treatment complications.No device malfunctions or other noteworthy events occurred during the case.

• 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: 22118958
• Report Number: 3027664504-2025-00009
• Device Sequence Number: 20627076
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K233466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female