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

Catalog Number	SR-014-GW
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/10/2025
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 prior to a transcarotid artery revascularization (tcar) procedure, the physician identified a clamp injury on a cta from a previous procedure.During tcar procedure, while crossing the lesion, the enroute 014 guidewire caused a dissection.The physician believes that the dissection was caused by the challenging anatomy due to the clamp injury.The physician addressed the dissection with the planned stent and completed the procedure with no health consequences or impact to the patient.
Additional Manufacturer Narrative
Complaint investigation completed as part of this report.
Event or Problem Description
It was reported that prior to a transcarotid artery revascularization (tcar) procedure, the physician identified a clamp injury on a cta from a previous procedure.During tcar procedure, while crossing the lesion, the enroute 014 guidewire caused a dissection.The physician believes that the dissection was caused by the challenging anatomy due to the clamp injury.The physician addressed the dissection with the planned stent and completed the procedure 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: amy carter ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 21737614
• Report Number: 3006010712-2025-00017
• Device Sequence Number: 14454911
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)280131(10)8804603
• 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): 05/20/2025

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 Catalogue Number: SR-014-GW
• Device Lot Number: 8804603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2025
• 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
• Patient Sex: Unknown