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

Model Number	SR-5035-BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a hematoma and vessel damage, leading to open surgery and additional covered stent placement.An enroute inflate transcarotid rx balloon was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.An enroute stent was implanted and post dilated using the inflate balloon.The procedure was completed without issue, and final images revealed nothing notable.The patient was moved to the post anesthesia care unit (pacu), and shortly thereafter developed a hematoma.The patient was brought back to the operating room and a redo tcar was performed, at which point vessel damage was noted.An additional covered stent was placed to treat the vessel damage.The physician suspected that the vessel damage may have occurred during post-dilation of the stent.The patient remained hospitalized at the time of reporting.

• 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: 23698393
• Report Number: 2124215-2025-88397
• Device Sequence Number: 10375929
• Product Code: LIT
• UDI-Device Identifier: 00811311021017
• UDI-Public: (01)00811311021017(17)270123(10)413521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/02/2025

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-5035-BC
• Device Catalogue Number: SR-5035-BC
• Device Lot Number: 0000413521
• 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: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 02/01/2024
• 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: 84 YR
• Patient Sex: Male
• Patient Race: White