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	Vasoconstriction (2126)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
Patient had a left tcar.Procedure was performed in normal tcar fashion.Dr.(b)(6) placed the soft portion the enroute 0.014 wire in a tortuous ica.During removal of the sds the wire advanced distal a bit.When doing the completion angio after the 3 min washout there was a narrowed area in the distal ica distal to the bend of the ica.Dr.(b)(6) was contacted and did review the images.Patient woke up nero intact.Dr.(b)(6) is planning to do an us tomorrow to evaluate the area patient present at time of event?: yes patient complications: no patient complications.As reported device codes: 1258: device operates differently than expected.As reported patient codes: 9296: vasospasm.
Additional Manufacturer Narrative
Complaint investigation has been completed as part of this report.
Event or Problem Description
Patient had a left tcar.Procedure was performed in normal tcar fashion.Dr.(b)(6).Placed the soft portion the enroute 0.014 wire in a tortuous ica.During removal of the sds the wire advanced distal a bit.When doing the completion angio after the 3 min washout there was a narrowed area in the distal ica distal to the bend of the ica.Dr.M was contacted and did review the images.Patient woke up nero intact.Dr.W is planning to do an us tomorrow to evaluate the area patient present at time of event? yes, patient complications: no patient complications.As reported device codes: 1258: device operates differently than expected.As reported patient codes: 9296: vasospasm.

• 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, H91CK-22 ; EI H91CK22
• MDR Report Key: 22608453
• Report Number: 3006010712-2025-00034
• Device Sequence Number: 5383894
• Product Code: DQX
• UDI-Device Identifier: 10816349014854
• UDI-Public: (01)10816349014854(17)290228(10)9656951
• 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): 08/28/2025

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: 9656951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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