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); Pseudoaneurysm (2605); Renal Impairment (4499); Biliary Leak (4820)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, as part of the boombox clinical study, a 33 year old female patient with a history of colorectal cancer with metastases to the liver received histotripsy treatment to 2.5 cm lesion in liver segment iv for a total planned treatment volume (ptv) of 22.4 cc.The procedure involved two overlapping ptvs to achieve full tumor coverage.The tumor was abutting the left portal vein and bile duct.Heparin was administered immediately prior to each treatment.The patient had previously undergone a right hepatectomy.No comorbidities were present, and renal function was normal prior to treatment.Post-procedure, the patient experienced bleeding into the treatment zone with pseudoaneurysm formation, identified on immediate post-operative ct.A hemoglobin drop was noted on overnight labs.The patient received a transfusion on the evening of (b)(6).Also, on that day serum creatinine increased to 3.0 mg/dl and continued to rise until dialysis was initiated on (b)(6).The patient was discharged on (b)(6) and continued outpatient dialysis.As of (b)(6), the patient remains on dialysis but continues to produce urine.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the case.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.".
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the case.The treating physician deemed this subsequent adverse event to be device and procedure related.
Event or Problem Description
As part of ongoing sequalae relative to histotripsy treatment, the patient developed a bile leak and subsequently required biliary stent placement for management as well as hospitalization.

• 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: 23707693
• Report Number: 3027664504-2025-00034
• Device Sequence Number: 10691736
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: 33 YR
• Patient Sex: Female