MAUDE Adverse Event Report: LAKE REGION MEDICAL COURIER, XFIRM, S, HY 195-014

Catalog Number	DS2G004
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway.
Event or Problem Description
Today a couple of hours after a successfully crt implant procedure, the patient suffered a pericardial effusion.The guidewire used to position the crt lead supposedly perforated the target vessel.The effusion resulted in a cardiac tamponade; so the patient underwent cardio-"thoracic" surgery to resolve the issue.During this procedure the quartet1456q crt lead was removed and a new epicardic bipolar lead was implanted.Patient conditions are good and stable.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.
Event or Problem Description
Today a couple of hours after a successfully crt implant procedure, the patient suffered a pericardial effusion.The guidewire used to position the crt lead supposedly perforated the target vessel.The effusion resulted in a cardiac tamponade; so the patient underwent cardio-toracic surgery to resolve the issue.During this procedure the quartet1456q crt lead was removed and a new epicardic bipolar lead was implanted.Patient conditions are good and stable.

• Brand Name: COURIER, XFIRM, S, HY 195-014
• Common Device Name: COURIER, XFIRM, S, HY 195-014
• 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: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 22183552
• Report Number: 3006010712-2025-00027
• Device Sequence Number: 20979653
• Product Code: DQX
• UDI-Device Identifier: 15414734505182
• UDI-Public: (01)15414734505182(17)260930(10)8639947
• Combination Product (Y/N): N
• 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): 06/27/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: DS2G004
• Device Lot Number: 8639947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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