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

Model Number 407200

Device Problems Fracture (1260); Material Twisted/Bent (2981)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, it was noted the tip of the needle was fractured and could not cross the septal.The needle was exchanged and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

During analysis the needle was found to be bent and not fractured, making this event not reportable.One brk transseptal needle/stylet assembly was received for evaluation.There was no evidence of a needle tip fracture; however, the needle tip had been bent.The needle had been bent in multiple locations.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information received indicates the stylet was not used and the needle was pre-shaped prior to use.Artmt600087496 ver.A brk transseptal needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the brk transseptal needle (ifu) also states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.Failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator.¿ the cause of the reported event is consistent with not following the instructions for use.

• 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: 15192282
• MDR Text Key: 302945743
• Report Number: 3008452825-2022-00540
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 8122310
• 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: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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