MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Bacteremia (4846)
Date of Event	11/18/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Infections are documented perioperative risks for brain surgeries such as mri-guided neurosurgical ablation.This documentation is available in the neuroblate ifu and in monteris' internal risk management files.No malfunction was alleged; therefore, no device evaluation was performed.
Event or Problem Description
According to a remaster sae form, it was reported on post-litt procedure day 18, the patient presented to the er due to decreased appetite and increased generalized weakness.The patient was too weak to attend her oncology appointment, and it was recommended that she go in.Upon arrival, her heart rate was in the 130s, and her systolic blood pressure was 69-78.She was admitted to the icu for hemodynamic management.Chest imaging indicated moderate to large right pleural effusion with mild to moderate layering left pleural effusion.Blood culture came back positive for haemophilus influenzae, and urine culture was positive for klebsiella pneumoniae.On post-study procedure day 27, the patient remained afebrile and hemodynamically stable.White blood cell count continued to increase, and chest imaging showed large right pleural effusion with near complete compressive atelectasis.Ct also showed dilated stomach and distal small bowel with decompressed colon suggestive of bowel obstruction.The patient remained on antibiotics without improvement.On post-study procedure day 28, patient had a cough and decreased saturations overnight.White blood cell count continued to increase without signs of infection.She required increased oxygen.She was started on a clear, liquid diet and expressed that she did not want to undergo another thoracentesis.She transitioned to inpatient hospice.On post-study procedure day 29 (b)(6) 2024, the patient "gradually deteriorated and died peacefully".The sae was deemed by the treating physician to be not related to the litt device or litt procedure; however, on (b)(6) 2025 the remaster safety committee deemed the event as possibly related to the litt procedure, as well as possibly related to the surgical procedure and possibly related to steroid therapy.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: michelle bergstrom ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 23436631
• Report Number: 3009970070-2025-00016
• Device Sequence Number: 14648177
• Product Code: GEX
• UDI-Device Identifier: 00816589021080
• UDI-Public: 00816589021080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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 Model Number: 20980
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2015
• 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; Death
• Patient Sex: Unknown