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	Nausea (1970); Vomiting (2144); Ambulation or Postural Difficulties (2544); Confusion/ Disorientation (2553)
Date of Event	05/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction was reported.
Event or Problem Description
An 87-year-old female with cholangiocarcinoma metastatic to the liver, enrolled in the boombox study, had a histotripsy treatment on (b)(6) 2025.The patient had a metal stent and was discharged on antibiotics.On may 5, 2025, the patient's son called the site and reported that the patient had experienced nausea, vomiting, slight confusion and unable to ambulate and had been admitted on (b)(6) 2025.Per the investigator's clinic note, the patient received iv fluid resuscitation and iv zosyn (piperacillin/tazobactam) and was discharged on (b)(6) 2025 with iv ertapenem with an end date of may (b)(6) 2025.The investigator reassured the patient's son to discontinue antibiotics on (b)(6) 2025.Per the last clinic note, the patient was improving.Patient reportedly had a metal stent, this could have lead to cholangitis and hypotension.The investigator noted that the adverse event was probably related to histotripsy treatment.No device malfunctions or other noteworthy event 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: 22204497
• Report Number: 3027664504-2025-00011
• Device Sequence Number: 6755364
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 03/21/2024
• 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: 87 YR
• Patient Sex: Female