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

Model Number 407200

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/14/2023

Event Type  Injury  

Event 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.

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.

• Brand Name: BRK¿ 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: 18367009
• MDR Text Key: 331016194
• Report Number: 3008452825-2023-00580
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072278
• 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,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• 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