MAUDE Adverse Event Report: CLEARPOINT NEURO CLEARPOINT NEURO; SMARTFRAME ACCESSORY KIT

Catalog Number	NGS-AK-01-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device performed as intended throughout the procedure and no malfunction occurred.There was no evidence suggesting that the bleeding was related to clearpoint neuro products.There is no tangible clinical risk to having these products continued to be distributed and used in the field.The surgical team appeared to use the products in accordance with the intended use.The patient was unable to receive iv contrast that shows the brain vasculature in detail, which increased the risk of bleeding from blood vessels present (but not visualized) in any planned entry and trajectory.Additional sequences, including fgatir, t2 and mprage were examined during the planning and operative portion of the case to ensure as safe an approach as possible, though they may not showcase the vascularity as well as iv contrast depending on the scanner and technique used to acquire them.
Event or Problem Description
On (b)(6) 2024, a bilateral deep brain stimulation (dbs) lead implantation procedure was performed using the clearpoint system (clearpoint software version 2.1) and associated accessories for placement of the dbs leads.When reviewing the mri scans after removing the stylet from the peel away sheath, bleeding was noted through the peel away sheath along the right trajectory.The patient was then transferred to the operating room and the procedure using clearpoint neuro's products was aborted.Clearpoint neuro products were used as intended throughout the procedure.

• Brand Name: CLEARPOINT NEURO
• Common Device Name: SMARTFRAME ACCESSORY KIT
• Manufacturer (Section D): CLEARPOINT NEURO; 6349 paseo del lago; carlsbad CA 92011
• Manufacturer (Section G): CLEARPOINT NEURO; 6349 paseo del lago; carlsbad CA 92011
• Manufacturer Contact: megan faulkenberry ; 6349 paseo del lago; carlsbad, CA 92011
• MDR Report Key: 19779718
• Report Number: 3028006458-2024-00001
• Device Sequence Number: 4148387
• Product Code: HAW
• UDI-Device Identifier: 00850359007157
• UDI-Public: 00850359007157
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K200079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2026
• Device Catalogue Number: NGS-AK-01-11
• Device Lot Number: FA2403034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Prefer Not To Disclose