MAUDE Adverse Event Report: Contego Medical, Inc. Neuroguard IEP System; Stent, Carotid

Model Number	NG-0740-140-2
Medical Device Problem Codes	Break (1069); Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Neuroguard IEP System
• Common Device Name: Stent, Carotid
• Manufacturer (Section D): Contego Medical, Inc.; 3801 lake boone trail; suite 100; raleigh NC 27607
• Manufacturer (Section G): Contego Medical, Inc.; 3801 lake boone trail; suite 100; raleigh NC 27607
• Manufacturer Contact: james clossick ; 3801 lake boone trail, suite 100; raleigh, NC 27607 ; +1(305)607-1708
• MDR Report Key: 50111153
• Report Number: 3011471056-2026-00055
• Device Sequence Number: 10753817
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P240009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/01/2026

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: NG-0740-140-2
• Device Catalogue Number: NG-0740-140-2
• Device Lot Number: Z2460909B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011471056/06252026/R/00
• Patient Sequence Number: 1
• Patient Sex: Unknown