MAUDE Adverse Event Report: HISTOSONICS, INC. EDISON SYSTEM; 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	Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events were reported by the user.
Event or Problem Description
As part of the boombox post-market clinical trial, a 52 year old female patient, diagnosed with metastatic leimyosarcoma, had a histotripsy treatment to a segment 5 liver tumor on (b)(6) 2025 (total planned treatment volume (ptv) = 33.5cc ).After the histotripsy treatment, the patient experienced significant abdominal pain and brown urine which resulted in the patient being admitted day of the procedure.A post-procedure ct scan indicated stable duodenitis and no active gastrointestinal bleed.According to the treating physician, the duodenum was reported to be adjacent and potentially overlapping the ptv, which may have resulted in the patient developing duodenitis.The patient was given antibiotics, held for observation and discharged on (b)(6) 2025.As part of the boombox post-market clinical trial, the treating physician determined on (b)(6) 2025 that the duodenitis was grade 3 due to the need for admission.The patient is recovering well and no further "sequelae" were experienced.No device malfunctions or other noteworthy events occurred during the case.

• Brand Name: EDISON SYSTEM
• Common Device Name: Focused ultrasound system for non-thermal, mechanical tissue ablation
• Manufacturer (Section D): HISTOSONICS, INC.; 16305 36th ave n; suite 300; plymouth MN 55446
• Manufacturer (Section G): HISTOSONICS, INC.; 16305 36th ave n; suite 300; plymouth MN 55446
• Manufacturer Contact: leeanne swiridow ; 16305 36th ave n; suite 300; plymouth, MN 55446 ; 6123510361
• MDR Report Key: 22014586
• Report Number: 3027664504-2025-00008
• Device Sequence Number: 7837747
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/13/2025

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: 04/14/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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; Other
• Patient Age: 52 YR
• Patient Sex: Female