MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE .014" GUIDEWIRE

Catalog Number	SR-014-GW
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, the physician failed to cross the lesion with the enroute 0.14" guidewire while using a balloon catheter for support.When exchanging for another 0.14" guidewire, the physician noted a piece of the original 0.14" guidewire just outside the tip of the 8f enroute sheath.The broken wire piece was removed through the incision in the common carotid artery.Another 0.14" guidewire was used, and the procedure was completed with no health consequences or impact to the patient.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.
Event or Problem Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, the physician failed to cross the lesion with the enroute 0.14" guidewire while using a balloon catheter for support.When exchanging for another 0.14" guidewire, the physician noted a piece of the original 0.14" guidewire just outside the tip of the 8f enroute sheath.The broken wire piece was removed through the incision in the common carotid artery.Another 0.14" guidewire was used, and the procedure was completed with no health consequences or impact to the patient.

• Brand Name: ENROUTE .014" GUIDEWIRE
• Common Device Name: ENROUTE .014" GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 21909339
• Report Number: 3006010712-2025-00022
• Device Sequence Number: 17164938
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)260331(10)6902015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 6902015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Sex: Unknown