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

Catalog Number	NGS-AK-01-11-5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a bilateral deep brain stimulation (dbs) lead implantation procedure was performed using the clearpoint software version 2.1 and associated clearpoint system accessories for placement of the dbs leads.When reviewing the mri scans after drilling two cranial burr holes and inserting the stylets, a hematoma was noted on the patient's left side.The patient was then transferred to the operating room and the procedure using clearpoint neuro's products was aborted.Post-procedure, the surgeon confirmed that the clot was successfully evacuated.Clearpoint neuro products were used as intended throughout the procedure.
Additional Manufacturer Narrative
Clearpoint neuro products performed as intended throughout the procedure and no malfunction occurred.There was no evidence suggesting that the hematoma 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.Patient and situational factors, including scheduling conflicts, different surgeons, absence of adequate preoperative imaging, patient's head shape and size, and significant surface vasculature in the ideal entry area contributed to a technically difficult case.Vascular injury occurred after drilling and stylet insertion, which resulted in significant bleeding that mandated further intervention.While this was not related to any clearpoint neuro product, process or action, the surgeon was presented with the option to move the entry point farther from the identified surface artery on the left side and choose not to do this, which may have contributed to the injury.Finally, although the clinical team supports the case as appropriate, the hand drill ifu includes a caution statement about this situation, placing the onus on the surgical team to ensure safety, stating "there is an inherent risk in creating access through the skull that the device may cause a subdural bleed.Monitor drilling progress closely during usage.".

• 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: 20625308
• Report Number: 3028006458-2024-00004
• Device Sequence Number: 15316662
• Product Code: HAW
• UDI-Device Identifier: 00850359007812
• UDI-Public: 00850359007812
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/06/2024

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 Catalogue Number: NGS-AK-01-11-5
• 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: 10/16/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown