MAUDE Adverse Event Report: LAKE REGION MEDICAL 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	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation underway as part of this complaint.
Event or Problem Description
Event description: ecn event description: dr.Isolated the carotid artery and used our micropuncture kit to obtain access.He took an angiogram which did not depict any abnormalities, then used our 0.035' j wire to place the 8f arterial sheath into the artery using the stop short method.Flow reversal was connected and the carotid artery was clamped.Dr.Took another angiogram to obtain our working image for pre-dilation and stent placement this showed no abnormalities.He then advanced the 0.014' guidewire into the ica and confirmed location by guiding it into the petrous ridge portion of the skull base.Dr.Used a viatrac balloon for pre-dilation, placed an enroute stent, and post-dilated with another viatrac balloon.After the 2min washout period another angiogram was obtained.There was a potential dissection noted just beyond the distal portion of the stent in the ica.Dr.Took another angiogram in a different angle to confirm and decided to place a second stent distal to the first stent in order to cover the potential dissection.A second stent was placed, two minute washout period was observed and another angiogram done.Dr.Was satisfied with the second stent placement and completed the case.The patient woke up post-surgery neurologically intact with no complaints.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: additional stent deployed to cover dissection patient admitted to hospital beyond the standard of care: no patient outcome: fully recovered.Event date: 2025-11-3.As reported device codes: 2099: no known device problem.As reported patient codes: 9071: dissection.
Additional Manufacturer Narrative
Complaint investigation completed as part of this report.
Event or Problem Description
Event description: ecn event description: dr.Isolated the carotid artery and used our micropuncture kit to obtain access.He took an angiogram which did not depict any abnormalities, then used our 0.035' j wire to place the 8f arterial sheath into the artery using the stop short method.Flow reversal was connected and the carotid artery was clamped.Dr.Took another angiogram to obtain our working image for pre-dilation and stent placement this showed no abnormalities.He then advanced the 0.014' guidewire into the ica and confirmed location by guiding it into the petrous ridge portion of the skull base.Dr.Used a viatrac balloon for pre-dilation, placed an enroute stent, and post-dilated with another viatrac balloon.After the 2min washout period another angiogram was obtained.There was a potential dissection noted just beyond the distal portion of the stent in the ica.Dr.Took another angiogram in a different angle to confirm and decided to place a second stent distal to the first stent in order to cover the potential dissection.A second stent was placed; two minute washout period was observed and another angiogram done.Dr.Was satisfied with the second stent placement and completed the case.The patient woke up post-surgery neurologically intact with no complaints.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: additional stent deployed to cover dissection patient admitted to hospital beyond the standard of care: no patient outcome: fully recovered.Event date: 2025-11-3.As reported device codes: 2099: no known device problem.As reported patient codes: 9071: dissection.

• Brand Name: ENROUTE,ST,MOD,S,HY,US 95-014
• 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; parkomre west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: barbara krason ; parkomre west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 23615901
• Report Number: 3006010712-2025-00042
• Device Sequence Number: 13006160
• 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): 12/03/2025

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: 9705779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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