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	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
Ecn event description: null patient present at time of event?: yes patient complications: other provide details for "other" patient complication: dissection in lcca in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: unknown medical or surgical interventions: additional enroute stent used to cover dissection patient outcome: expected to fully recover.
Additional Manufacturer Narrative
Complaint investigation is completed.
Event or Problem Description
Ecn event description: null patient present at time of event? yes, patient complications: other provide details for "other" patient complication: dissection in lcca in the physician's opinion, did the device or procedure cause or contribute to the patient complication? unknown medical or surgical interventions: additional enroute stent used to cover dissection patient outcome: expected to fully recover.

• 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: 22059732
• Report Number: 3006010712-2025-00025
• Device Sequence Number: 18259917
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)280229(10)8846864
• 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,Followup
• Report Date (Section B): 06/10/2025

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: 8846864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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