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

Model Number	NG-0730-140-2
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the neuroguard was prepped according to the ifu with no issue.Device was positioned within the lesion for treatment.The target vessel was the lica/lcca.Blue outer sheath was retracted to expose the ng [neuroguard] filter, filter deployment knob was turned counterclockwise according to the ifu, but the filter was initially unresponsive opening.The six filter markers were visualized opening completely as the blue sheath was retracting back deploying the sheath.Stent was deployed and the case was completed.Upon visual inspection for debris in the filter on the back table post procedure, the filter was unresponsive to opening using the filter deployment knob.The procedure was completed with no incident or complication.
Additional Manufacturer Narrative
Investigation details: the distal end of the filter chassis to the activation wire joint was examined under magnification and was found intact and undamaged.Handle wheel was rotated to open the filter frame chassis which did open, but with delay.Handle covers and handle halves were removed, exposing the activation wire to hypotube to spring to handle screw joint.This joint was intact and undamaged.Device functioned properly other than the none smooth/responsive movement of the filter frame chassis.Examination of the shaft found a kink/buckled location on the blue sheath.Product evaluation conclusion: the filter frame chassis' slow response to movement of its activation wire can be due to the dried blood and decontamination solution in the lumen housing containing the activation wire.These dried materials can restrict the smooth movement of the activation wire that opens and closes the filter frame chassis.The kinked/buckled sheath could have occurred during shipping and may not have been present during the use of the device.However, if the user did accidentally kink the device during insertion and then continued to use the device, the kink will cause restriction on the activation wire which will cause a delayed response to handle wheel rotation.The user did not notice any delayed filter frame chassis movement during prep so the kink was not present prior to loading the device into the patient.The filter frame chassis did open up to its fully specified diameter of 7 - 7.5 mm.This mdr is a remedial submission made in direct response to fda form 483 observations to ensure full reporting compliance.The associated compliant was originally classified as non-reportable; however, following a retrospective reassessment, the manufacturer determined that the event meets the reportability criteria under 21 cfr part 803.This submission fulfills our commitment to correct the initial reporting determination.

• 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; 3801 lake boone trail,; suite 100; raleigh NC
• Manufacturer Contact: james clossick ; 3801 lake boone trail; suite 100; raleigh, NC 27607 ; 3056071708
• MDR Report Key: 25414379
• Report Number: 3011471056-2025-00019
• Device Sequence Number: 9551293
• Product Code: NIM
• UDI-Device Identifier: 00851616007606
• UDI-Public: 00851616007606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P240009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: Z2460578F
• 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: 02/25/2025
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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
• Patient Sex: Male
• Patient Weight: 66 KG