MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE,ST,MOD,S,HY,US 95-014; ENROUTE 014 GUIDEWIRE

Model Number	901047-01
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation completed as part of this report.
Event or Problem Description
Ecn event description: patient prepped and draped in sterile fashion.The carotid artery was exposed and upon access of the cca with the enroute mpk the access wire was difficult to advance.The mpk sheath was retracted slightly and then the wire was advanced.The eca was selected, the stiff j-wire was inserted and the nps arterial sheath was inserted.The procedure continued normally, until the clamp was applied and the.014 wire was introduced.It advanced seemingly normally until midway up the cca.After some manipulation the wire was advanced further up past the bifurcation.It was decided to take an angio as the wire placement could not be confirmed.The angio showed the wire directed more towards the eca.The wire was retracted and a new.014 wire was inserted.After some manipulation it was advanced into the ica and to the petrous ridge.Angioplasty and stenting was performed and after a 2 min wash time angiography was performed.A significant dissection was observed in the cca from the sheath tip up to the carotid bifurcation.It was decided to place a 2nd stent to tack down the dissection.After placement of the 2nd stent angiography was performed demonstrating no visible dissection or flow disruption in the cca.The clamp was removed and all devices were removed.Hemostasis was obtained and the surgical pocket was closed.The patient awoke neurologically inact.The patient was discharged the following day without any known complications.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: new wire was used what is the next course of action?: na patient present at time of event?: yes patient complications: no patient complications patient outcome: fully recovered event date: 2025-12-11 as reported device codes: 1274: difficult to advance as reported patient codes: 9398: no clinical signs, symptoms or conditions.

• Brand Name: ENROUTE,ST,MOD,S,HY,US 95-014
• 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: barbara krason ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 24080495
• Report Number: 3006010712-2026-00001
• Device Sequence Number: 18585919
• Product Code: DQX
• UDI-Device Identifier: 00816349014857
• UDI-Public: 00816349014857
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/15/2026

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 Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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