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	Adult Respiratory Distress Syndrome (1696); Cardiac Arrest (1762); Respiratory Acidosis (2482); Thrombosis/Thrombus (4440)
Date of Event	04/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
No other device malfunctions or other noteworthy events occurred during the case.
Event or Problem Description
As part of the boombox post-market clinical trial, patient id (b)(6), died due to what the treating physician believes to be a thromboembolic event possibly related to the histotripsy device and histotripsy procedure performed on (b)(6) 2025.An 87 year old male patient with a history of sigmoid colon cancer, which had been resected 4 years prior, received histotripsy treatment on (b)(6) 2025 to 2 lesions in segments v (x=25 mm, y=30 mm, z = 30 mm, ptv = 29.3 cc) and vi (x=18 mm, y=22 mm, z = 14.5 mm, ptv = 11.5 cc) for a total planned treatment volume (ptv) 40.8 cc.Per the treating physician, no anti-coagulation therapy was provided prior to the histotripsy procedure.The patient had previously undergone sbrt in (b)(6) 2023, which potentially overlapped with the histotripsy ptvs.During the intraoperative course, two system errors occurred which required a system reset resulting in a cumulative delay of approximately 30 minutes.The total procedure time under anesthesia was approximately 3.5 hours.Per the treating physician, the patient's immediate post procedure recovery was uneventful.He exhibited normal neurological function, was alert, ambulating, and able to tolerate oral intake.He was transferred to the post-anesthesia care unit (pacu) in stable condition with plans for postoperative imaging, including a ct scan.While being transported for imaging, the patient suffered a cardiac arrest.Resuscitation efforts were extensive, involving 30 minutes of cardiopulmonary resuscitation (cpr) and the administration of thrombolytic therapy.Return of spontaneous circulation was achieved; however, the patient subsequently developed acute respiratory distress syndrome (ards).The patient then experienced refractory metabolic acidosis.Despite aggressive critical care interventions, the patient showed no signs of recovering, and following discussions with the family, life-sustaining treatments were withdrawn.The patient was pronounced deceased on (b)(6) 2025.A transthoracic echocardiogram performed during the resuscitation period demonstrated preserved cardiac function.No postoperative imaging was obtained.It was noted that the patient had no history of arrhythmia.For trial purposes, the event was classified by the treating physician as possibly related to the device and possibly related to the procedure.Per the treating physician, the most probable contributing factors were perioperative immobility and the absence of heparin prophylaxis.Given the patient's clinical course and known risks, this event was considered anticipated.This mdr is being submitted out of an abundance of caution due to the patient's death post-procedure although no definitive cause of death was determined.No other 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: 21989353
• Report Number: 3027664504-2025-00006
• Device Sequence Number: 8030204
• Product Code: QGM
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/08/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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; Hospitalization; Death
• Patient Age: 87 YR
• Patient Sex: Male