MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; EMBOLIC PROTECTION FILTERING GUIDEWIRE

Model Number	FG12531
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
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 was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The physician reported that the arterial sheath was difficult to insert.Post procedure, the arterial sheath was removed and inspected, and it was noticed that the black tip of catheter was bent to side and the plastic lumen was exposed.There was no report of vessel injury.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.This report is being submitted to correct the reported h6 - device codes.
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 was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The physician reported that the arterial sheath was difficult to insert.Post procedure, the arterial sheath was removed and inspected, and it was noticed that the black tip of catheter was bent to side and the plastic lumen was exposed.There was no report of vessel injury.

• 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 ; 7634941632
• MDR Report Key: 24747697
• Report Number: 2124215-2026-17747
• Device Sequence Number: 8780046
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 06/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/21/2026; 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 97648381-FA
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White