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

Model Number	NG-0740-140-2
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a procedure involving the neuroguard stent iep sys ng-0740-140-2, the filter partially opened and then "snapped" closed, and the wire that actuates the filter snapped and poked through the filter.The issue occurred while attempting to open the filter on the back table, submerged in a saline bowl with the stylet in place, and the wire snapped as the actuator knob was fully engaged.A.014 4-7mm non-medtronic (abbott emboshield) filter wire was intended to be used.The device was never implanted or introduced into the patient.The case was completed using an ng-0640-140-2 neuroguard device without any problem.
Additional Manufacturer Narrative
Contego medical is filing this mdr in compliance with the guidance "medical device reporting for manufacturers guidance for industry and food and drug administration staff", section 2.21, usa food and drug administration, november 8, 2016.

• 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 ; 3056071708
• MDR Report Key: 25783093
• Report Number: 3011471056-2026-00031
• Device Sequence Number: 10753117
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/10/2026
• 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