MAUDE Adverse Event Report: CONTEGO MEDICAL, INC NEUROGUARD IEP SYSTEM; CAROTID STENT

Model Number	NG-0730-140-2
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description removal difficulties.Neuroguard (stent delivery catheter, as the stent was successfully deployed, and the difficulties were upon delivery catheter removal) would not come out of co-pilot, doctor removed co-pilot with device leaving wire in and reattaching co-pilot.Procedure went good till removing neuroguard from sheath/ co-pilot.The device was pulling out like normal till near the rapid exchange wire port.The co-pilot was held wide open, but the neuroguard would not come out.The physician had to remove the co-pilot from the sheath and remove the neuroguard over the wire and replace the co-pilot onto the sheath over the wire.The device was safely removed from the patient, and the procedure was completed after removal.No patient complications have been reported as a result of this event.Investigation: device discarded, no investigation device possible.Per the ifu, the neuroguard should be used with a rotating hemostatic valve.(the co pilot manufactured by abbott vascular, is not a rotating hemostatic valve, instead is a spring loaded compression hemostatic valve.) suspected primary cause: the most probable contributing factor is the use of a co-pilot hemostatic valve, which can interfere with the neuroguard product 's outer member.Conclusions the neuroguard product was used with a non rotating hemostatic valve, contrary to the ifu, this led to the reported removal difficulties.Based on the available information, there is no evidence of a device malfunction.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 24772657
• Report Number: 3011471056-2026-00044
• Device Sequence Number: 20349830
• Product Code: NIM
• UDI-Device Identifier: 00851616007606
• UDI-Public: 00851616007606
• 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
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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-0730-140-2
• Device Catalogue Number: NG-0730-140-2
• Device Lot Number: Z2461012F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 04/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COPILOT ABBOTT VASCULAR
• Patient Sex: Unknown