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

Model Number G407209

Device Problems Difficult to Insert (1316); Component Misassembled (4004)

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: 3008452825-2020-00638, 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 device was not returned.However, the event was confirmed to be manufacturing related.An incorrect brk-1 needle, xs sharp packaging issue has been confirmed for lot 7620873.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the investigation performed and the information provided the cause of the even was determined to be manufacturing related.As a result of this finding, abbott is performing further investigation.

• Brand Name: BRK-1 XS 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
• MDR Report Key: 10864634
• MDR Text Key: 217093561
• Report Number: 3008452825-2020-00639
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 7620873
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK XS; BRK XS