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

Model Number	G407209
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, an air leak occurred.Once the needle was inserted into the patient, when attempting to pull blood back, air entered the system.It seemed the threading between the flush and needle was not tight.The needle was replaced and the procedure continued with no patient consequences.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h3.One brk transseptal needle was received for evaluation.The stylet was not returned.There were multiple bends throughout the needle.No other visual anomalies were noted.The needle was flushed, no resistance was noted.A stylet from current inventory was fully inserted and removed; no resistance was noted.The needle was flushed with fluid using a slip tip syringe; no functional anomalies were noted.An aspiration vacuum leak test was conducted; no air aspirated into the syringe.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.The brk transseptal needle instructions for use (ifu) states, ¿the use of a slip-tip (non-luer-lock¿) syringe may prevent aspirating air.¿.

• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18940233
• Report Number: 3008452825-2024-00153
• Device Sequence Number: 6770128
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G407209
• Device Lot Number: 10084016
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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