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	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ecn event description: access and lesion evaluation were done in standard tcar protocol, tcar time out was done and landmarks were identified.The wire was advanced through the lesion a slight buckling was noted and wire was pulled back and readvanced smoothly through the ica to the petrous ridge.Procedure was done 2 stents were placed.3 minute washout time was followed.Slow flow and petrous ridge was not identified in the completion angio.Ivus was utilized to identify if a dissection was present in the distal ica it was noted to extend into the proximal petrous ridge.An additional 5x 40 cprdis precise stent and 7x30 enroute stent were used to cover the dissection.2 minute washout was done completion angio show brisk flow to the brain.Patient woke with full movement, and uniform facial response.It was noted that the patient had sever pain in her 'molars' and subsequent ct post procedure showed no bleeding what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? it was noted a flow limiting dissection distal to our lesion into the petrous ridge what is the next course of action?: two additional stents were needed to resolve the dissection and return flow patient present at time of event? yes, patient complications: no patient complications.
Additional Manufacturer Narrative
Investigation underway as part of this complaint.
Additional Manufacturer Narrative
Investigation completed as part of this report.
Event or Problem Description
Ecn event description: access and lesion evaluation were done in standard tcar protocol, tcar time out was done and landmarks were identified.The wire was advanced through the lesion a slight buckling was noted and wire was pulled back and readvanced smoothly through the ica to the petrous ridge.Procedure was done 2 stents were placed.3 minute washout time was followed.Slow flow and petrous ridge was not identified in the completion angio.Ivus was utilized to identify if a dissection was present in the distal ica it was noted to extend into the proximal petrous ridge.An additional 5x 40 cprdis precise stent and 7x30 enroute stent were used to cover the dissection.2 minute washout was done completion angio show brisk flow to the brain.Patient woke with full movement, and uniform facial response.It was noted that the patient had sever pain in her 'molars' and subsequent ct post procedure showed no bleeding.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? it was noted a flow limiting dissection distal to our lesion into the petrous ridge.What is the next course of action? two additional stents were needed to resolve the dissection and return flow.Patient present at time of event? yes.Patient complications: no patient complications.

• 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: barbara krason ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 23096453
• Report Number: 3006010712-2025-00039
• Device Sequence Number: 8581970
• Product Code: DQX
• UDI-Device Identifier: 00816349014857
• UDI-Public: (01)00816349014857(17)290228(10)9656949
• 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): 10/13/2025

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
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 9656949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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