MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE 0.014'' GUIDEWIRE

Catalog Number	SR-014-GW
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left transcaphoid artery revascularization (tcar) procedure, the 0.014" enroute guidewire looped when exiting the arterial sheath resulting in a dissection at the sheath tip.The physician used another 0.014" enroute guidewire to complete the procedure and an unplanned additional stent was placed to cover the dissection.There were no further complications reported.

• Brand Name: ENROUTE 0.014'' GUIDEWIRE
• Common Device Name: 0.014'' GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, 91385 037; EI 91385037
• MDR Report Key: 21314754
• Report Number: 3014526664-2025-00014
• Device Sequence Number: 8848891
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)270930(10)8639846
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025
• Report Date (Section F): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 8639846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/05/2025