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	Gastrointestinal Hemorrhage (4476); Renal Impairment (4499)
Date of Event	06/03/2025
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
A 74-year-old female with a history of colorectal cancer metastatic to the liver underwent histotripsy treatment on (b)(6) 2025, targeting segment iv.Four overlapping lesions were treated with a total planned treatment volume (ptv) of 111 cc.The procedure was completed without device malfunction or intra-procedural complications.The histotripsy treatment included an area abutting the gallbladder, with portions of the gallbladder encompassed within the ptv.The treating physician proceeded with full awareness of the potential risk of hemorrhage associated with gallbladder involvement, which was observed in the ct immediately post procedure.Hemoglobin remained stable and the patient exhibited no signs or symptoms of cholecystitis until (b)(6) which was managed by placement of a percutaneous cholecystostomy tube on (b)(6).At the time of treatment, the patient was actively receiving capecitabine, oxaliplatin, and bevacizumab, with no treatment holiday.Following the procedure, the patient developed acute kidney injury (aki), with creatinine rising to 2.85 mg/dl and egfr declining to (b)(6).She remained anuric and required initiation of dialysis on the same day.As of (b)(6), she remains hospitalized, requiring intermittent hemodialysis with no evidence of renal recovery or creatinine clearance between dialysis sessions.Discharge planning is underway, with anticipated transfer to a rehabilitation facility or skilled nursing facility capable of providing dialysis.She has no other systemic symptoms, and her liver function tests normalized quickly post-procedure.

• 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: 22371455
• Report Number: 3027664504-2025-00014
• Device Sequence Number: 20855820
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2024
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female