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

Model Number	G407209
Medical Device Problem Codes	Difficult to Insert (1316); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation procedure, a small blood clot was noted on the needle.Transeptal puncture (with a stylet) was difficult and required multiple attempts to cross the septum.After one of the attempts, the needle was removed from the patient and it was noticed that then needle could not be flushed or drawn back.The physician asked for another needle and the case continued without any adverse events.The original needle was later checked outside the patient by reinserting the dilator and a small blood clot was pushed out of the needle and the needle could be flushed easily.
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 blood clot remains unknown.

• Brand Name: BRK-1¿ XS 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: 19105986
• Report Number: 3008452825-2024-00200
• Device Sequence Number: 18076741
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: (01)05414734205184(10)10012539(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/26/2024

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: G407209
• Device Lot Number: 10012539
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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: Female
• Patient Weight: 94 KG