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

Model Number 407200

Device Problem Difficult to Insert (1316)

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

Event Date 07/24/2023

Event Type  Injury  

Event Description

During a supraventricular tachycardia procedure, an additional femoral and atrial puncture were needed due to insertion difficulties.A reshaped needle was used but could not puncture the atrial septum.A new transseptal needle and access and puncture point were used with the original sheath to complete with procedure with no further issues.

Manufacturer Narrative

One brk transseptal needle was received for evaluation.The needle had been bent at the distal curve area.The formed curve of the needle was no longer consistent with specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information received indicates the needle was pre-shaped prior to use.The brk transseptal needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the cause of the reported event is consistent with not following the instructions for use.

Manufacturer Narrative

Additional information received indicated the femoral vein puncture was not redone, therefore this event is not reportable.

Event Description

During a supraventricular tachycardia procedure, there were insertion difficulties.The transseptal needle could not puncture the atrial septum.A new transseptal needle was used with the original sheath to complete with procedure with no further issues.Additional information received indicated the femoral vein puncture was not redone, therefore this event is not reportable.

• Brand Name: BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• 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: 17573700
• MDR Text Key: 321450522
• Report Number: 3008452825-2023-00350
• 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,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407200
• Device Lot Number: 8735408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/25/2023; 02/08/2024
• Supplement Dates FDA Received: 09/08/2023; 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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