MAUDE Adverse Event Report: LAKE REGIONMEDICAL 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	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: ecn event description: patient was having a symptomatic right tcar with dr.Patient was filtered through the allina system and transfemoral stenting was attempted first but because of the tortuosity of the ica a filter couldn't be passed so patient was referred to vascular surgery.Stroke was over 3 months ago, and the patient symptoms had resolved.There is no p2y12 testing but patient was on aspirin, plavix and statin.All products were prepped and set up correctly.The physician tunneled our sheath and when he advanced the.035 wire it moved freely, and a good "j" was formed.8fr sheath was advanced without any difficulty.At this point he connected the sheaths to our neuroprotection system, and we took our working views.No dissection was noted but we did discuss the severity of the tortuosity in the distal ica.Patient was then put on flow reversal and we confirmed with a saline syringe.The.014 was advanced with some difficulty but due the patient anatomy and severity of tortuosity in the distal ica the physician said it was probably due to that so we proceeded with the procedure.On post imaging a dissection was noted proximal to stent and there was not adequate flow in the ica.Dr then covered that dissection with a 10x40 stent but the post imaging still showed inadequate in the ica.After more imaging it was clear the first stent was deployed in a dissection plane.At this point the tcar was aborted and the physician converted to cea and explanted the stents.A successful cea was performed and patient was neuro intact post procedure.Post imaging was performed by dr and no dissection was noted.After the surgery the physician believes the.014 is what caused the dissection and due to the severity of the tortuosity the wire was very difficult to manipulate.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: see above what is the next course of action?: see above patient present at time of event?: yes patient complications: no patient complications patient outcome: fully recovered.Event date: 2026-1-2 as reported device codes: 1274: difficult to advance as reported patient codes: 9071: dissection procedure date: (b)(6) 2026.
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 REGIONMEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGIONMEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: barbara krason ; parkmore west business park; galway, H910C-K22 ; EI H910CK22
• MDR Report Key: 24115955
• Report Number: 3006010712-2026-00003
• Device Sequence Number: 14919554
• Product Code: DQX
• UDI-Device Identifier: 00816349014857
• UDI-Public: 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): 01/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 9705780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/20/2026
• 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