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	Angina (1710); Hemoptysis (1887); Myocardial Infarction (1969)
Date of Event	05/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction was reported.
Event or Problem Description
A 70-year-old male patient with a history of stage iv squamous cell carcinoma of the tongue with lung and liver metastases received histotripsy treatment on (b)(6) 2025 as part of the boombox study.No device malfunctions or other noteworthy events occurred during the procedure.On (b)(6) 2025, the patient was admitted to hospital for hemoptysis and during hospitalization experienced chest pain the following day.Patient has a clinical history of coronary artery disease and received coronary artery bypass graft in 2003.On (b)(6), the patient had 2/4 patent grafts and received a new occluded saphenous vein graft to right coronary artery graft.Treatment included: heparin and dual antiplatelet therapy with aspirin and plavix.No additional intervention was required.On (b)(6), high-sensitivity troponin i (tnih) was 3,790 which indicated a cardiac event had occurred.The patient was discharged on (b)(6) and the patient was directed to follow up as outpatient.Due to the fact that the histotripsy treatment was on (b)(6) and the chest pain was a non-st-elevation myocardial infarction (nstemi) which occurred on (b)(6) (10 days later), the investigator determined it could possibly related to the histotripsy procedure, and therefore we are reporting this event out of an abundance of caution.

• 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: 22204498
• Report Number: 3027664504-2025-00012
• Device Sequence Number: 6755365
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 05/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male