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

Model Number 407201

Device Problems Improper or Incorrect Procedure or Method (2017); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  malfunction  

Event 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.

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
• 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: 17174966
• MDR Text Key: 317869901
• Report Number: 3008452825-2023-00264
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sex: Male