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

Model Number	SR-5535-BC
Medical Device Problem Codes	Material Integrity Problem (2978); Failure to Deflate (4060)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the enflate balloon would not deflate, resulting in additional intervention.An enroute enflate transcarotid rx balloon dilatation catheter was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.During removal, the enflate balloon would not deflate and caused a dissection in the internal carotid artery (ica).The physician used a stiff wire to puncture the balloon and removed it out through the enroute arterial sheath.The dissection was treated with a planned stent.Additionally, it was also reported that upon removal, the shaft of the enflate balloon was split in half.

• 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: 22730904
• Report Number: 2124215-2025-50051
• Device Sequence Number: 13009258
• Product Code: LIT
• UDI-Device Identifier: 00811311021024
• UDI-Public: (01)00811311021024(17)280326(10)466110
• 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): 08/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-5535-BC
• Device Catalogue Number: SR-5535-BC
• Device Lot Number: 0000466110
• 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: 07/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 03/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White