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	Bacterial Infection (1735); Bacteremia (4846)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product sterility issues were identified.Investigation/dhr review confirmed that the disposable products utilized in this case were sterilized per procedure and met sterility requirements.Infections a documented perioperative risk for brain surgeries such as mri-guided neurosurgical ablation.This documentation is available in the neuroblate ifu and in monteris' internal risk management files.
Event or Problem Description
According to a remaster sae form, it was reported that a patient experienced a fever of unspecified origin and rapid change in mental status on (b)(6) 2025 after a litt procedure on (b)(6) 2025.This event was deemed as a serious reportable adverse event since the treating physician determined the event was possibly related to the litt procedure and required a new hospitalization and surgical intervention.Patient was sent to an outside hospital where blood cultures were taken (later growing serratia).Brain mri was obtained; ablation cavity overall looks fairly similar to postoperative scan, though there are small amounts of diffusion restriction overlying the frontal lobe.On (b)(6) 2025, it was observed that overall, the patient's mental status improved since diagnosis while on antibiotics; however, mental status continues to wax and wean.Repeat brain mri was obtained demonstrating concern for progressive intracranial infection.The patient underwent a surgical washout with cultures and was provided medication including steroids.
Event or Problem Description
According to a remaster sae form, it was reported that a patient experienced a fever of unspecified origin and rapid change in mental status on (b)(6) 2025 after a litt procedure on (b)(6) 2025.This event was deemed as a serious reportable adverse event since the treating physician determined the event was possibly related to the litt procedure and required a new hospitalization and surgical intervention.Patient was sent to an outside hospital where blood cultures were taken (later growing serratia).Brain mri was obtained; ablation cavity overall looks fairly similar to postoperative scan, though there are small amounts of diffusion restriction overlying the frontal lobe.On (b)(6) 2025, it was observed that overall, the patient's mental status improved since diagnosis while on antibiotics; however, mental status continues to wax and wean.Repeat brain mri was obtained demonstrating concern for progressive intracranial infection.The patient underwent a surgical washout with cultures and was provided medication including steroids.On 15oct2025, additional information from the remaster sae was retrieved during a remaster safety committee meeting, during which the treating physician confirmed that the event was determined to be a non-neurological bacteremia or sepsis.On post-study procedure day 39 ((b)(6) 2025), the patient was discharged from the inpatient rehabilitation facility to a subacute rehabilitation facility in a stable condition, with plans of continuing pt, ot, and st.She was still noting headaches and was experiencing impairment in gait and cognition/communication skills.On post-study procedure day 51 ((b)(6) 2025), infectious disease noted that the patient would continue receiving iv antibiotics to address the infection.The event was indicated as ongoing at study exit on (b)(6) 2025.
Additional Manufacturer Narrative
No product sterility issues were identified.Investigation/dhr review confirmed that the disposable products utilized in this case were sterilized per procedure and met sterility requirements.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.This supplementary is being submitted to capture the additional information received from the event.

• 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: 22977415
• Report Number: 3009970070-2025-00011
• Device Sequence Number: 18499284
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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
• Patient Sex: Unknown