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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM
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MONTERIS MEDICAL NEUROBLATE® SYSTEM Back to Search Results
Model Number 20360
Medical Device Problem Code Computer Software Problem (1112)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/07/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during an ablation procedure, there was a blue pixel "bowtie" that was witnessed.The user let off the foot pedal during the treatment but this did not help dissipate the blue pixels.It was noted there was a biopsy performed that was a single core.There were no patient complications reported in relation to this event.
 
Additional Manufacturer Narrative
Device evaluation: the cold pixel phenomenon was confirmed during the case.
 
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Brand Name
NEUROBLATE® SYSTEM
Common Device Name
NEUROBLATE® SYSTEM
Manufacturer (Section D)
MONTERIS MEDICAL
14755 27th ave n
suite c
plymouth MN 55447
MDR Report Key7899496
Report Number3009970070-2018-00072
Device Sequence Number168955
Product Code GEX
UDI-Device Identifier00816589020656
UDI-Public00816589020656
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K173305
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 09/21/2018
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
Initial Date Received by Manufacturer 09/07/2018
Supplement Date Received by Manufacturer10/02/2018
Initial Report FDA Received Date09/21/2018
Supplement Report FDA Received Date10/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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