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	Perforation of Vessels (2135)
Date of Event	01/03/2025
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 transaortic artery revascularization (tcar) procedure, the enroute 014 guidewire caused a perforation.The physician placed 2 additional stents to address the perforation.Imaging after stent deployment revealed the perforation had not resolved and was causing disruptions in flow through the stents.The physician elected to convert the procedure to cea and the stents were explanted.
Event or Problem Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, the enroute 014 guidewire caused a perforation.The physician placed 2 additional stents to address the perforation.Imaging after stent deployment revealed the perforation had not resolved and was causing disruptions in flow through the stents.The physician elected to convert the procedure to cea and the stents were explanted.
Additional Manufacturer Narrative
Complaint investigation is completed.

• 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: 21301485
• Report Number: 3006010712-2025-00006
• Device Sequence Number: 18354943
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)271031(10)8639852
• 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): 02/07/2025

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: 8639852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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