MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION BOLT-MINIBOLT (2.2)

Model Number	20755
Medical Device Problem Codes	Unintended Magnet Quench (1377); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the bolt was being placed with a starfix stereotactic device.Prior to the insertion of the probe, the 2.2mm dilator was inserted.It was intended to be passed to 1cm short of the target in order to confirm placement.However, the scan showed that the dilator was passed 2.5cm deeper and near the patient's optic nerve.It was noted that the patient had no deficits upon waking up; it should also be noted that the tolerance of the starfix-neuroblate adapter was too tight which caused the physician to put a lot of force on the dilator upon insertion.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.

• Brand Name: BOLT-MINIBOLT (2.2)
• Common Device Name: BOLT-MINIBOLT (2.2)
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6740563
• Report Number: 3009970070-2017-00114
• Device Sequence Number: 1291732
• Product Code: GEX
• UDI-Device Identifier: 00816589020755
• UDI-Public: 00816589020755
• 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
• Report Date (Section B): 07/25/2017

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: 20755
• Device Catalogue Number: CMB022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1