MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER; CATHETER, PERCUTANEOUS

Model Number	SR-5025-BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred requiring additional intervention.An enroute enflate transcarotid rx balloon dilatation catheter was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The patient presented as asymptomatic.The clamp was on and flow reversal was established.When attempting to cross the lesion with the 0.014 guidewire, the enflate balloon unintentionally led the wire, resulting in a dissection of the left common carotid artery (cca).The true lumen was accessed and an additional enroute stent was used to cover the dissection.The tcar procedure was successfully completed.After closure of the carotid artery, ultrasound was used to interrogate the access site for remaining dissection.This was negative for dissection.The patient was expected to fully recover.

• Brand Name: ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22060059
• Report Number: 2124215-2025-32510
• Device Sequence Number: 8328957
• Product Code: LIT
• UDI-Device Identifier: 00811311020942
• UDI-Public: (01)00811311020942(17)270123(10)413520
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SR-5025-BC
• Device Catalogue Number: SR-5025-BC
• Device Lot Number: 0000413520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White