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

Model Number	NG-0730-140-2
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a neuroguard stent iep system was being prepared for use for a right proximal internal carotid artery procedure when the filter wheel would not open the filter during preparation.It just spun freely back and forth.It is suspected that the internal wire weld broke off.The instructions for use were reported to have been followed with the stylet put back in as well.The device was not used in a patient and was never implanted.A 6fr non-medtronic (cook shuttle) sheath was intended to be used.The procedure was completed using a new neuroguard 9/7/8x40 device.There was no patient involved.
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: 25784049
• Report Number: 3011471056-2026-00041
• Device Sequence Number: 10656008
• Product Code: NIM
• UDI-Device Identifier: 00851616007606
• UDI-Public: 00851616007606
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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-0730-140-2
• Device Catalogue Number: NG-0730-140-2
• Device Lot Number: Z2460900B
• 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: 08/13/2025
• 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: Male