MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION SIDEFIRE DIRECTIONAL LASER PROBE; SIDEFIRE¿ DIRECTIONAL LASER PROBE

Catalog Number	NBP-000-01
Medical Device Problem Codes	Charred (1086); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2017
Type of Reportable Event	Death
Event or Problem Description
It was reported that during an ablation procedure, a dialogue box stating that there was an error condition preventing temperature monitoring.Also, a dialogue box stating that there was no probe connected.The thermocouple temperature was erratic upon start of header scan and thermometry.It was noted that the probe cables redirected inside bore without successfully changing thermocouple behavior when scanning.Upon removing the probe, the tip looked black inside.Ultimately, the probe was exchanged for a new probe.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 probe was returned and had black artifact at the distal end.Residual adhesive coating was present on the thermocouple, and the thermocouple remains intact.The probe temperature reading was observed during the case along with the black artifact on the distal end of the probe align with unintended thermocouple heating.
Event or Problem Description
Additional information received indicated that the patient experienced a hemorrhage following the procedure and ultimately expired.
Additional Manufacturer Narrative
The patient adverse event of hemorrhage is a known risk of brain surgery.

• Brand Name: SIDEFIRE DIRECTIONAL LASER PROBE
• Common Device Name: SIDEFIRE¿ DIRECTIONAL LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6807030
• Report Number: 3009970070-2017-00129
• Device Sequence Number: 121235
• Product Code: GEX
• UDI-Device Identifier: 00816589020540
• UDI-Public: 00816589020540
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081509
• 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,Followup,Followup,Followup
• Report Date (Section B): 08/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2018
• Device Catalogue Number: NBP-000-01
• Device Lot Number: C7435-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 08/25/2017; 11/09/2017; 04/30/2018
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 08/21/2017; 09/14/2017; 11/13/2017; 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR