MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, towards the end of the ablation blue pixels started to appear in the noise mask.The user was instructed to stop delivering laser energy so the blue pixels would disappear per the normal workaround for this issue.However, the blue pixels did not disappear after more than a minute of waiting.The laser was continued and the blue pixels were noted as artifact.There were no patient complications reported in relation to this event.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the incorrect temperature data set, as well as the incorrect tdt (thermal dose threshold) lines, were displayed by the software due to a sudden change within the physical anatomy of the brain area near the probe.The software did not malfunction in this case.The software calculated, and displayed the temperature based on the corrupt input data from the mri.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 7036903
• Report Number: 3009970070-2017-00174
• Device Sequence Number: 16430457
• Product Code: GEX
• UDI-Device Identifier: 00816589020403
• UDI-Public: 00816589020403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1