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

Model Number	407201
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrioventricular reentrant tachycardia/left lateral accessory pathway ablation procedure, an air leak occurred.The needle was replaced and the procedure was completed with no adverse patient consequences.When the needle was inserted into the sheath and was attempted to be manually flushed prior to transseptal puncture, air bubbles were noticed to be consistently pulled back with the saline syringe.The physician believes it was an issue with the valve on the needle itself.The needle was replaced with another needle and the procedure was completed with no adverse patient consequences.It was confirmed that the physician utilized a luer lock syringe with the transseptal needle.
Additional Manufacturer Narrative
One brk transseptal needle/stylet assembly was received for evaluation.No functional anomalies were noted when the needle was flushed, and an air aspiration test was performed using a slip tip syringe.Device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Brk transseptal needle instructions for use (ifu) states, ¿the use of a slip-tip (non-luer-lock¿) syringe may prevent aspirating air.¿ based on the received condition of the device and the information provided, the cause of the reported air leak remains unknown.

• 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: 17174966
• Report Number: 3008452825-2023-00264
• Device Sequence Number: 20129788
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 8912673
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: Male