MAUDE Adverse Event Report: CLEARPOINT NEURO CLEARPOINT NEURO; SMARTFRAME XG SCALP MOUNT BASE

Model Number	NGS-SM-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device performed as intended throughout the procedure and no device 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.As witnessed by the need for additional same-day imaging and length of the non-operative planning, the patient's anatomy may have presented unique challenges for the surgery, including but not limited to, challenges associated with the blood vessels of the bone/dura/brain, skull flexibility/ shape/thickness, and surface organization of sulci and gyri.These patient-specific anatomic challenges most likely contributed to abnormal bleeding despite appropriate performance of the product and surgery team.No corrective actions are necessary at this time.This issue shall continue to be monitored.
Event or Problem Description
A bilateral responsive neurostimulation (rns) lead implantation procedure was performed using the clearpoint system and associated accessories for placement of the rns leads.When reviewing the mri scans after drilling two 14mm cranial burr holes and mounting the scalp mount bases on each side, a subdural bleed was noted on the patient's right side.The patient was then transferred to the operating room and the procedure using clearpoint neuro's products was aborted.Per confirmation of the clinical specialist supporting this procedure, the bleeding was observed in two locations: 1) near the anterior bone screw of the scalp mount base mounted on the right side, 2) near the posterior and lateral side of the right burr hole.Clearpoint neuro products were used as intended throughout the procedure.As of (b)(6) 2024, the surgeon confirmed that the patient is doing well and is expected to be discharged.

• Brand Name: CLEARPOINT NEURO
• Common Device Name: SMARTFRAME XG SCALP MOUNT BASE
• 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: 19794861
• Report Number: 3028006458-2024-00002
• Device Sequence Number: 4149089
• Product Code: HAW
• UDI-Device Identifier: 00850359007324
• UDI-Public: 00850359007324
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200079
• Exemption Number: 0
• 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): 07/22/2024

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: 07/22/2024
• Device Model Number: NGS-SM-01
• Device Catalogue Number: NGS-SM-01
• Device Lot Number: FA2207046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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: 3 YR
• Patient Sex: Prefer Not To Disclose