MAUDE Adverse Event Report: LAKE REGION MEDICAL 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	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) obtained access to the cca utilizing the silk road micropuncture kit.An angiogram was performed which showed no abnormalities.The 0.035' guidewire from the enroute neuroprotection kit was then inserted into the cca using the stop short method.The microsheath was removed and the 8f arterial sheath from the enroute nps kit was inserted.The flow controller tubing was connected from the arterial sheath, primed, and connected to the venous sheath.Act and vitals were in the appropriate ranges for the carotid was clamped.Another angiogram was taken which did not show any visible abnormalities.Dr.(b)(6) attempted to advance the 0.014' enroute guidewire but the wire appeared to prolapse mid cca and was behaving abnormally.He gently pulled the sheath tip back and rotated the c-arm to take another angiogram.There was concern for a dissection at this point, so dr.(b)(6) removed the 8f sheath from the cca, closed the puncture site with the 5.0 prolene pre-stitch, and reaccessed more proximal this time.Using the same steps as before, he safely inserted the 8f arterial sheath again and reconnected the whole circuit with the flow controller tubing.An additional angiogram was taken.Dr.(b)(6) attempted to advance the 0.014' enroute wire and could not engage the true lumen.He tried an 0.014' whisper wire as well and still could not stay true lumen.At this point dr.(b)(6) decided to convert to cea.Upon conversion the dissection plane was confirmed on the posterior wall of the cca.Dr.(b)(6) completed the cea without complications and the patient woke up following surgery neurologically intact.Patient present at time of event? yes, patient complications: dissection in the physician's opinion, did the device or procedure cause or contribute to the patient complication? no medical or surgical interventions: tcar was converted to cea patient admitted to hospital beyond the standard of care: no patient outcome: fully recovered event date: 2026-2-2 as reported device codes: 1258: device operates differently than expected, 1274: difficult to advance as reported patient codes: 9398: no clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
Complaint investigation 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 bussines 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: 24387825
• Report Number: 3006010712-2026-00006
• Device Sequence Number: 10240531
• Product Code: DQX
• UDI-Device Identifier: 00816349014857
• UDI-Public: (01)00816349014857(17)310729(10)9888568
• 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): 02/19/2026

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: 9888568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/19/2026
• 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