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

Catalog Number	SR-014-GW
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right transcarotid artery revascularization (tcar) procedure, the enroute 0.014" guidewire caused a perforation.Additionally, the physician reported that the lesion was difficult to cross and multiple third-party wires were used.The physician placed two additional stents to address the perforation.However, imaging after stent deployment revealed that the perforation had not resolved and was causing disruptions in flow through the stents.The physician elected to convert the procedure to carotid endarterectomy (cea), explant the stents, and tack down the intima distally.

• 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: 21234026
• Report Number: 3014526664-2025-00009
• Device Sequence Number: 9077014
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)271031(10)8639852
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/24/2025
• Report Date (Section F): 01/24/2025

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: 8639852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• 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: 87 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/24/2025