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	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this repor.
Event or Problem Description
It was reported that after a right tcar procedure, the patient failed the post procedure neurocheck and couldn't move their left arm.Additional information stated that the patient experienced hypotension after the procedure, the patient was on dapt and a p2y12 test revealed the patient was therapeutic.Imaging revealed thrombus in the stent, and thrombectomy was performed.The patient has not returned to baseline.Additionally, it was reported that there was dissection in the distal ica near the petrous ridge, where the enroute 014 wire interacts.
Event or Problem Description
It was reported that after a right tcar procedure, the patient failed the post procedure neurocheck and couldn't move their left arm.Additional information stated that the patient experienced hypotension after the procedure, the patient was on dapt and a p2y12 test revealed the patient was therapeutic.Imaging revealed thrombus in the stent, and thrombectomy was performed.The patient has not returned to baseline.Additionally, it was reported that there was dissection in the distal ica near the petrous ridge, where the enroute 014 wire interacts.
Additional Manufacturer Narrative
Complaint investigation has been completed as part of this report.

• 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: 21803525
• Report Number: 3006010712-2025-00020
• Device Sequence Number: 18034562
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)270930(10)8557113
• 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): 05/09/2025

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: 8557113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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