MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number G407208

Device Problem Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing ref: 3008452825-2020-00639, 3008452825-2020-00642.During the procedure, a clinically significant delay occurred to puncture difficulties.During transseptal puncture, difficulty was noted puncturing the septum while using an sl0 sheath with a brk xs transseptal needle.A brk-1 xs needle was then obtained and when attempting to puncture the septum, the puncture remained difficult.A third transseptal needle was tried with a brk xs needle which had the same problem.A brk-1 needle was then used with a swartz introducer to perform transseptal puncture successfully.The procedure was completed with no adverse patient consequences.A clinically significant delay occurred due to these issues.When comparing the brk¿ xs transseptal needle, 71 cm to the brk-1¿ xs, there was no difference in the curves.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: BRK XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10864734
• MDR Text Key: 217093578
• Report Number: 3008452825-2020-00638
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: G407208
• Device Catalogue Number: G407208
• Device Lot Number: 7396609
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK XS; BRK-1 XS; BRK XS; BRK-1 XS