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 Patient Involvement (2645)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the thermal dose threshold (tdt) lines showed up in an area cerebrospinal fluid and were also inaccurate at the bottom of the center slice.This created the need to interpolate the area that was thought to be true and disregard the supposed incorrect tdt lines.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the software logs were reviewed and it was determined that the target area was up against the ventricle, which was filled with cerebrospinal fluid (csf).There was no indication of software malfunction.The most probably explanation is that there was csf that was causing some degradation in the quality of the magnetic resonance imaging (mri) supplied data.

• 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: 6962765
• Report Number: 3009970070-2017-00158
• Device Sequence Number: 10904235
• 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): 10/19/2017

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: 09/22/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1