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

Model Number	NG-0630-140-2
Medical Device Problem Codes	Difficult to Insert (1316); Use of Device Problem (1670); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Contego medical was notified on the event on november 04, 2025.This mdr is being filed as a conservative measure.The device was not returned to the manufacturer for evaluation.Without the returned device, a physical or functional inspection could not be performed.The investigation was therefore based on the event description, information provided by the sales representative and attending physician.Based on the information received, the event is consistent with excessive force applied during device advancement and withdrawal after resistance was encountered.No patient harm was reported.Below are the details as reported.Event as reported.The neuroguard stent iep sys ng-0630-140-2 device was prepped according to ifu by fellow and attending.The fellow began to advance the delivery system over the non-medtronic (ez filterwire) guidewire that was already in place through a 6fr non-medtronic (shuttle) sheath.He experienced some friction and unfortunately kept pushing.The attending thinks the tuohy was too tight or the fellow was compressing the non-medtronic sheath while advancing the delivery system.The attending and sales rep said to pause and it was discovered that there was a thin wire coming out around the thumb wheel.It was decided the device was obviously compromised and needed to be removed.Due to the fact that the non-medtronic sheath was "bareback" the removal of the entire system with sheath was not able to be safely executed.The delivery system was removed and the device was believed to be deployed in the shuttle sheath.Imaging of the sheath by itself confirmed this.The device was broken into pieces because the fellow was pulling extremely hard when removing the system and we were trying to locate the stent.This was before the shuttle sheath was replaced and imaged separately.A second device was prepped and the attending decided to do it all himself.The second device was advanced and deployed without issue.Physician not concerned for any harm to the patient at all.No patient complications have been reported as a result of this event.On 19nov2025: additional information from rep - the device was prepped on the back table in the steps provided in ifu.The device was inserted into a guide catheter with appropriate id size according to ifu.I can confirm, myself and the attending, agree that the fellow pushed the device multiple times after resistance was felt.The attending is certain it was him and not the device.We used a second device; the attending had zero issues and will use the device again.

• 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: 23723448
• Report Number: 3011471056-2025-00076
• Device Sequence Number: 18802061
• Product Code: NIM
• UDI-Device Identifier: 00851616007583
• UDI-Public: 00851616007583
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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-0630-140-2
• Device Catalogue Number: NG-0630-140-2
• Device Lot Number: Z2460740B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH INTRODUCER.; TOUHY BORST VALVE.
• Patient Sex: Unknown