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	Low Blood Pressure/ Hypotension (1914); Urinary Retention (2119); Renal Impairment (4499)
Date of Event	04/22/2025
Type of Reportable Event	Death
Event or Problem Description
A 81-year-old male patient with advanced metastatic cholangiocarcinoma received repeat histotripsy treatment (initial treatment (b)(6) 2025, total ptv 49.0 cc) on (b)(6) 2025, to a single lesion in segment v, with two partially overlapping planned treatment volumes (ptvs) reported as ptv 1: total ptv = 31 cc, ptv 2: total ptv = 29.5cc, for a total ptv of 60.5 cc.The patient was discharged post-procedure without incident and ultimately returned home.On post-operative day 3 ((b)(6) 2025), he developed anuria, and his creatinine rose to 7.The treating physician reported that the patient underwent hemodialysis and had some urine output, with a diagnosis of acute tubular necrosis (atn) attributed to a combination of anesthesia, histotripsy, and nsaid use, with possible contribution from acute interstitial nephritis (ain).The patient remained dialysis-dependent, but on-going hypotension complicated management.The family ultimately elected to withdraw care and the patient died on (b)(6) 2025.No device malfunctions or other noteworthy events occurred during the case.
Additional Manufacturer Narrative
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: 22006894
• Report Number: 3027664504-2025-00007
• Device Sequence Number: 20131748
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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: 04/11/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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: Required Intervention; Death; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male