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	Visual Disturbances (2140); Vascular Dissection (3160); Ischemia Stroke (4418)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that fourteen days after a left transcarotid artery revascularization (tcar) procedure, the patient experienced visual disturbances.Imaging revealed a new narrowing near the distal portion of the stent, and the stent remained patent.The patient was compliant with dual antiplatelet therapy (dapt) and a p2y12 platelet function test revealed the patient was therapeutic.Follow up imaging revealed a dissection in the distal portion of the stented area believed to be caused by the 0.014" enroute guidewire, and thrombus was observed in the dissected area.An additional stent was placed to reline the area of dissection and the patient has returned to baseline.

• 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: 21711981
• Report Number: 3014526664-2025-00054
• Device Sequence Number: 9952424
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)270630(10)8210228
• 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: 8210228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/27/2025