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

Model Number	407201
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported clot could not be conclusively determined.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: 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
• Report Number: 3008452825-2024-00150
• Device Sequence Number: 2894293
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown