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	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ecn event description: after the karate sheet was placed, we noticed that the 014 wire was not behaving as normal.It was buckling.We took an angiogram and did not notice a dissection and decided to open a new 014 wire.The second wire was also behaving strangely took another angiogram still did not notice a dissection.Placed a 40 cm kumpe catheter onto the wire and it would not advance past the distal common carotid.Shot another angiogram and noticed the dissection.Patient present at time of event?: yes patient complications: dissection in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes please describe the way in which the device or procedure caused or contributed to the patient complication?: the left common carotid artery dissected while placing the 8fr carotid sheath medical or surgical interventions: conversion from tcar to cea patient admitted to hospital beyond the standard of care: no patient outcome: expected to fully recover this is the third lot number impacted by this issue as confirmed by the customer (b)(6) 2026.A ship history was completed, and these are the 3 lot numbers that are associated with these complaints (b)(4).
Additional Manufacturer Narrative
Complaint investigation completed as part of this report.

• 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: 50426900
• Report Number: 3006010712-2026-00015
• Device Sequence Number: 10422861
• Product Code: DQX
• UDI-Device Identifier: 00816349014857
• UDI-Public: (01)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): 08/25/2026

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
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 10053396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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