MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE,ST,MOD,S,HY,US 95-014

Model Number	901047-01
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device/procedure outcome: unable to use device - attempted, procedure completed via alternative method.Patient outcome: additional surgery.Event description: carotid artery access was obtained and 8f arterial sheath was sutured in place from our enroute nps kit.Reverse flow tubing was connected and carotid was clamped.The enroute 0.014 guidewire would not advance.Dr.Took an angiogram and a dissection was noted.Dr.Could not get the guidewire to pass the dissection plane and stay true lumen, therefore he elected to convert the case to cea.Patient complications: no patient complications reason for unsuccessful procedure: reverse flow connected and carotid artery clamped dissection noted upon entry of 0.014 wire and physician could not pass wire to engage lesion, so converted to cea.
Event or Problem Description
Device/procedure outcome: unable to use device - attempted,procedure completed via alternative method patient outcome: additional surgery event description: carotid artery access was obtained and 8f arterial sheath was sutured in place from our enroute nps kit.Reverse flow tubing was connected and carotid was clamped.The enroute 0.014 guidewire would not advance.Dr.Took an angiogram and a dissection was noted.Dr.Could not get the guidewire to pass the dissection plane and stay true lumen, therefore he elected to convert the case to cea.Patient complications: no patient complications reason for unsuccessful procedure: reverse flow connected and carotid artery clamped dissection noted upon entry of 0.014 wire and physician could not pass wire to engage lesion, so converted to cea.
Additional Manufacturer Narrative
Complaint investigation has been completed as part of this investigation.

• Brand Name: ENROUTE,ST,MOD,S,HY,US 95-014
• Common Device Name: ENROUTE,ST,MOD,S,HY,US 95-014
• 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: 22531355
• Report Number: 3006010712-2025-00032
• Device Sequence Number: 20816359
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)280229(10)8846865
• 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): 08/27/2025

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: 8846865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown