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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM
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MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM Back to Search Results
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 10/09/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the bolt caused pixel drop, did not show thermal dose threshold (tdt) lines, and signal loss.The bolt was said to cause artifact in the brain for superficial lesions.This artifact caused an issue with the treatment of the patient's lesion due to the lesion being so superficial, along with the pixel drop and tdt lines.There were no patient complications reported in relation to this event.
 
Additional Manufacturer Narrative
Device evaluation: the bolt caused a signal void in the mri images.
 
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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 Key6984227
Report Number3009970070-2017-00160
Device Sequence Number16314843
Product Code GEX
UDI-Device Identifier00816589020403
UDI-Public00816589020403
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K162762
Number of Events Summarized1
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) 10/27/2017
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 Number20360
Device Catalogue NumberNB102
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/09/2017
Supplement Date Received by Manufacturer11/15/2017
Initial Report FDA Received Date10/27/2017
Supplement Report FDA Received Date12/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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