MAUDE Adverse Event Report: LAKE REGION MEDICAL 901047-01; 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	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ecn event description: after insertion of arterial sheath and performing initial angiogram physician tried to advance guidewire into the vessel and was unable to advance wire through lesion.Advised doctor to perform another angiogram in another orthogonal view to check for coaxial sheath position.Physician did not want to make another angiogram at this time and requested another wire.Multiple attempts made to guide wire through lesion without success.Advised physician to take another angiogram.Upon angiogram, dissection noted in common carotid artery distal to sheath insertion site.Advised physician to reposition sheath and try to guide wire out of dissection.Unable to guide wire out of dissection.Advised physician to close arteriotomy site and try to access again.Physician opted to abort tcar procedure and do carotid endarterectomy.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: carotid endarterectomy patient admitted to hospital beyond the standard of care: no patient outcome: unknown.Event date: 2025-10-16.As reported device codes: no value found.As reported patient codes: no value found.Procedure date: (b)(6) 2025.Type of procedure: transcarotid artery revascularization.
Additional Manufacturer Narrative
Investigation underway as part of this complaint.
Event or Problem Description
Ecn event description: after insertion of arterial sheath and performing initial angiogram physician tried to advance guidewire into the vessel and was unable to advance wire through lesion.Advised doctor to perform another angiogram in another orthogonal view to check for coaxial sheath position.Physician did not want to make another angiogram at this time and requested another wire.Multiple attempts made to guide wire through lesion without success.Advised physician to take another angiogram.Upon angiogram, dissection noted in common carotid artery distal to sheath insertion site.Advised physician to reposition sheath and try to guide wire out of dissection.Unable to guide wire out of dissection.Advised physician to close arteriotomy site and try to access again.Physician opted to abort tcar procedure and do carotid endarterectomy.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: carotid endarterectomy patient admitted to hospital beyond the standard of care: no patient outcome: unknown event date: 2025-10-16.As reported device codes: no value found.As reported patient codes: no value found.Procedure date: (b)(6) 2025.Type of procedure: transcarotid artery revascularization.
Additional Manufacturer Narrative
Investigation completed as part of this report.

• Brand Name: 901047-01
• 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: 23449135
• Report Number: 3006010712-2025-00041
• Device Sequence Number: 18189743
• 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,Followup
• Report Date (Section B): 11/14/2025

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 Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 9705781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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