MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Neuroprotection System; Embolic protection filtering guidewire

Model Number	FG12531
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the arterial sheath was difficult to insert, and the tip was found to be damaged.An enroute transcarotid neuroprotection system (nps) was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The physician encountered resistance while attempting to engage the artery with the arterial sheath.The arterial sheath was removed and inspected, and it was noticed that the tip had a slight bevel.There was no report of vessel injury and a new nps device was used to complete the procedure.

• Brand Name: ENROUTE Transcarotid Neuroprotection System
• Common Device Name: Embolic protection filtering guidewire
• Manufacturer (Section D): Silk Road Medical; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): Silk Road Medical Inc.; 27th ave north plymouth; minneapolis MN 55447
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25448733
• Report Number: 2124215-2026-30786
• Device Sequence Number: 9557064
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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: FG12531
• Device Catalogue Number: FG12531
• Device Lot Number: 0000307226
• Was Device Available for Evaluation?: No
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 11/12/2025
• 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
• Patient Sex: Unknown