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

Model Number	SR-5535-BC
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number 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.
Event or Problem Description
It was reported that a dissection occurred, requiring an additional stent placement.An enroute enflate transcarotid rx balloon dilatation catheter was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.When attempting to cross the lesion with the 0.014 guidewire, the enflate balloon exited the sheath without the wire, resulting in a dissection of the common carotid artery (cca).The sheath was removed, and the physician re-accessed the artery.An additional stent was used to cover the dissection, and the procedure was successfully completed.
Event or Problem Description
It was reported that a dissection occurred, requiring an additional stent placement.An enroute enflate transcarotid rx balloon dilatation catheter was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.When attempting to cross the lesion with the 0.014 guidewire, the enflate balloon exited the sheath without the wire, resulting in a dissection of the common carotid artery (cca).The sheath was removed, and the physician re-accessed the artery.An additional stent was used to cover the dissection, and the procedure was successfully completed.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis, as it is still implanted.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.A ship history review for the reported upn was performed for the reporting customer.Batches (498905), (474255) and (474744) were most recently shipped to the reporting facility in the 3-year period preceding the procedure date.There were no manufacturing deviations for any of the three batch numbers that could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A risk review performed for the enroute enflate rx balloon device confirmed that the reported event is a known event defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.The lot number was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number 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.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24163696
• Report Number: 2124215-2026-04270
• Device Sequence Number: 21149402
• Product Code: LIT
• UDI-Device Identifier: 00811311021024
• UDI-Public: (01)00811311021024
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-5535-BC
• Device Catalogue Number: SR-5535-BC
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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: 82 YR
• Patient Sex: Female