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	07/20/2026
Type of Reportable Event	Malfunction

• 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; 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: 50067449
• Report Number: 3006010712-2026-00012
• Device Sequence Number: 10078011
• Product Code: DQX
• UDI-Device Identifier: 10816349014854
• UDI-Public: (01)10816349014854
• 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
• Report Date (Section B): 07/29/2026

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 Expiration Date: 08/31/2026
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 10177030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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