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	Aspiration/Inhalation (1725); Head Injury (1879); Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Pneumonia (2011); Urinary Retention (2119); Hematuria (2558); Aspiration Pneumonitis (4455); High White Blood Cell Count (4594); Kidney injury (4882)
Date of Event	07/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occured 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.".
Event or Problem Description
On (b)(6) 2025, a 79-year-old female patient with metastatic gallbladder cancer underwent histotripsy to three hepatic metastases across four treatment targets in the right liver for a total planned treatment volume (ptv) of 96.38 cc.Past medical history included cholecystectomy, pulmonary hypertension, premature ventricular contractions, and venous thromboembolism (on long-term xarelto).The anesthesiologist assessed the patient as moderate risk.The procedure itself was uneventful apart from transient hypotension and oliguria.By post-operative day (pod) 1, oliguria persisted and nephrology noted hematuria and proteinuria.On pod2, leukocytosis developed, blood cultures were obtained, and creatinine rose which indicated acute kidney injury.During this period, the patient fell and was found to be hypotension and minor head trauma (head ct normal).A chest/abdomen/pelvis (non-contrast) ct revealed aspiration pneumonia, right pneumothorax, pulmonary hypertension, pneumobilia, intrahepatic gas, and a necrotic hepatic collection, along with extensive hepatic and osseous metastases.By pod3, blood cultures grew streptococcus agalactiae (group b) and escherichia coli.On pod4, the patient progressed to septic shock with respiratory failure.Leukocytosis worsened with the source thought to be the aspiration pneumonia versus the necrotic liver collection.Drainage of the hepatic collection was planned, but the patient deteriorated further, and following family discussions, care was transitioned to comfort measures.The patient died later that day.The treating physician attributed renal dysfunction to acute kidney injury from the procedure and/or sepsis-related hypotension.Pneumonia, pneumothorax, and liver necrosis/abscess were considered procedure-related, though absence of recent imaging limited determination of whether pneumonia or abscess predated histotripsy.For the kidney failure, nephrologists concluded that there was non-nephrotic range proteinuria.Additional renal studies obtained were positive for anti-nuclear antibodies, with low c3 and c4.Wide, non-specific differential diagnosis, included "bacterial infections, viral infections, some malignancies, autoimmune conditions (systemic lupus erythematosus, mixed connective tissue disease, sjogren's syndrome, and rheumatoid arthritis), hereditary angioedema, and cryoglobulinemia.".

• 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: 22913647
• Report Number: 3027664504-2025-00018
• Device Sequence Number: 8863247
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/28/2025

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: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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; Death
• Patient Age: 79 YR
• Patient Sex: Female