MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; Trocar

Model Number G407211

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/06/2024

Event Type  Injury  

Event Description

During an atrial fibrillation procedure, a clot was noted in the needle.The physician had just crossed over to the left atrium when it was noted that he could no longer flush the needle.The dilator was left across and the needle was removed.When flushing the needle on the sterile table, a large clot was noted within the needle.The sheath was exchanged and the procedure was completed with no consequences to the patient.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: Trocar
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18913777
• MDR Text Key: 337778083
• Report Number: 3008452825-2024-00141
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G407211
• Device Lot Number: 10151207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other