MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20985
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hemorrhage/bleeding is 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
During an ablation procedure, it was reported that the surgeon acquired a ct to confirm laser delivery probe trajectory.The ct indicated intracranial hemorrhage, so the litt procedure was aborted to perform a decompressive craniotomy.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer (Section G): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: jordon honeck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 15292847
• Report Number: 3009970070-2022-00025
• Device Sequence Number: 7166811
• Product Code: GEX
• UDI-Device Identifier: 00816589021097
• UDI-Public: 00816589021097
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 20985
• Device Catalogue Number: NB102-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Patient Sex: Unknown