MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH; Trocar

Model Number 407201

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/21/2024

Event Type  Injury  

Event Description

During an atrial fibrillation ablation, a clot occurred which resulted in the cancellation of the procedure.In addition, there were communication issues with the amplifier.When the ablation catheter was inserted, it was unstable.Breathing was compensated but the catheter continued to oscillate more than usual.The amplifier was reconnected and restarted, but the issue persisted.Then the computer was restarted, and a new map was completed with the mapping catheter.A clot was then detected, so the procedure was suspended at that time.A transesophageal echocardiography was done prior to the procedure and there were no clots noted at that time.Due to the issue, the ablation catheter was not re-introduced into the patient, and it was not verified whether the issue persisted after restarting the computer.There was no intervention needed to treat the clot found during the procedure.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 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: 18944408
• MDR Text Key: 338159537
• Report Number: 3008452825-2024-00150
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 407201
• Device Lot Number: 10029195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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