MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE 0.014'' GUIDEWIRE

Catalog Number	SR-014-GW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right transcarotid artery revascularization (tcar) procedure, the patient failed the post procedure neurological check and couldn't move their left arm.Additional information stated that the patient's blood pressure dropped to 85 systolic after the procedure, the patient was compliant with dual antiplatelet therapy (dapt) and a p2y12 platelet function test revealed the patient was therapeutic.Imaging revealed thrombus in the stent, and thrombectomy was performed.The patient has not returned to baseline.Additionally, it was reported that there was a possible dissection in the distal internal carotid artery (ica) near the petrous ridge, where the 0.014" enroute guidewire interacts.The silk road medical executive medical director discussed the event with the physician and determined that the reported event of a thrombosed stent leading to an embolic event and thrombectomy was due to the dissection caused by the 0.014" enroute guidewire in the distal ica.

• Brand Name: ENROUTE 0.014'' GUIDEWIRE
• Common Device Name: 0.014'' GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, 91385 037; EI 91385037
• MDR Report Key: 21713599
• Report Number: 3014526664-2025-00053
• Device Sequence Number: 21364968
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)270930(10)8557113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025
• Report Date (Section F): 03/27/2025

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 Catalogue Number: SR-014-GW
• Device Lot Number: 8557113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/27/2025