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	Fatigue (1849); Fever (1858); Chills (2191); Low White Blood Cell Count (4433)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 65-year-old female with metastatic colon adenocarcinoma to the liver was enrolled in the post-market clinical trial, booombox and had histotripsy to one lesion in liver segment 4b (total planned treatment volume (ptv) of ~57 cc) on (b)(6) 2025.On (b)(6) 2025, the patient was referred to the emergency department after a three-week history of fever, chills, fatigue, and neutropenia.On admission, her white blood count was 2.67 k/l and anc (absolute neutrophil count) was ~800, which improved to 1,300 by (b)(6) as her fever resolved clinically.An abdominal mri on (b)(6) showed two known hepatic metastases and a new 6.1 × 3.7 cm peripherally enhancing, centrally necrotic lesion at the segment iv/v junction; although a diagnosis of necrotic metastasis was favored, superimposed infection could not be excluded and was treated according to standard site clinical practice.Blood cultures remained negative.
Additional Manufacturer Narrative
The treating physician attributed this as possibly related to the device and possibly procedure related.Histosonics is submitting this mdr due to this attribution.No device malfunction or other noteworthy events occurred during the 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: 22980915
• Report Number: 3027664504-2025-00020
• Device Sequence Number: 9370937
• 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): 09/05/2025

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: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: 65 YR
• Patient Sex: Female