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

Model Number	407200
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation surgery, after the puncture was completed, the needle was taken out for irrigation and it was noted that a large mass of blood clots was washed out from the inside of the needle.The operation went smoothly and finally completed without adverse effects on the patient.The patient does not have a history of blood clots.The doctor alleges that the blood clot were caused by the puncture needle.
Additional Manufacturer Narrative
One brk transseptal needle was received for evaluation.The stylet was not returned.No functional anomalies were noted when the needle was flushed and when an air aspiration test was performed using a slip tip syringe.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of patient blood clots within the needle remains unknown.
Event or Problem Description
Fda request to update device model information and corrected reportable aware date.Follow up report required.
Additional Manufacturer Narrative
**udi related data quality updates only**.
Additional Manufacturer Narrative
Udi related data quality updates only.
Event or Problem Description
This report includes updated device model information.

• Brand Name: BRK¿ 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: 18367009
• Report Number: 3008452825-2023-00580
• Device Sequence Number: 7856669
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: (01)05414734205092(10)9247540(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072278
• 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,Followup,Followup
• Report Date (Section B): 07/23/2024

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: 08/31/2026
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 9247540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 07/19/2024; 07/10/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/25/2024; 07/22/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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