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	Hemorrhage/Blood Loss/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Liver Damage/Dysfunction (1954); Ascites (2596); Renal Impairment (4499)
Date of Event	04/30/2025
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 36-year-old female diagnosed with cholangiocarcinoma (ccc) with liver metastases, underwent histotripsy treatment to three separate targets involving segments 2,3,3/4b, for a total ptv of 65 cm3.Intraoperative ultrasound imaging revealed potentially incomplete treatment of targets 1 and 2 due to assumed inadequate voltage thresholds established during the planning pulses workflow step.In response, the treating physician performed repeat treatments of these lesions using increased voltage settings while maintaining original planned treatment volume dimensions.Post-retreatment assessment indicated satisfactory treatment outcomes.During the retreatment of the second target, the anesthesiologist observed a small amount of blood in the urinary catheter.This was suspected to be related to mechanical irritation from catheter insertion.The patient's blood pressure transiently elevated to 180/100 mmhg, likely secondary to this irritation.The procedure was briefly paused, the edison device and support arm were removed to allow anesthetic evaluation, and the catheter was flushed - confirming no obstruction.After a 30-minute stabilization period, the procedure resumed and the third target was treated without further complication.Significant laboratory abnormalities were noted post-procedure, suggesting acute liver stress and acute kidney injury (aki).Due to the renal function observation, cross-sectional imaging (mri/ct) was deferred.A liver ultrasound showed normal hepatic artery flow, patent portal veins, no biliary ductal dilatation, and presence of ascites.In addition, the patient's creatinine levels increased over a 96 hour period.These findings are consistent with acute kidney injury likely related to procedural and post-procedural stress.Ongoing nephrology evaluation and supportive care were initiated, and continued follow-up is planned to monitor organ function and recovery as this is typically a transient and acute issue.The patient was discharged on may 8th in stable condition and continued to improve at home.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: 22118959
• Report Number: 3027664504-2025-00010
• Device Sequence Number: 7176305
• 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: 36 YR
• Patient Sex: Female