MAUDE Adverse Event Report: LAKE REGION MEDICAL CPS COURIER GUIDEWIRE

Catalog Number	DS2G002
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
Initial crt implantation.After placing the lv lead in the target vein, it was no more possible to put the wire out of the lead.The wire is torn off and got stuck in the electrode at the upper end.The lead was replaced.Good measurements.No patient complications.Stable patient.
Event or Problem Description
Initial crt implantation.After placing the lv lead in the target vein, it was no more possible to put the wire out of the lead.The wire is torn off and got stuck in the electrode at the upper end.The lead was replaced.Good measurements.No patient complications.Stable patient.
Additional Manufacturer Narrative
Complaint investigation is completed.

• Brand Name: CPS COURIER GUIDEWIRE
• Common Device Name: CPS COURIER 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: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 21353965
• Report Number: 3006010712-2025-00010
• Device Sequence Number: 8950328
• Product Code: DQX
• UDI-Device Identifier: 05414734505161
• UDI-Public: (01)05414734505161(17)270531(10)9076100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073082
• 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): 04/02/2025

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 Catalogue Number: DS2G002
• Device Lot Number: 9076100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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