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

Model Number 407200

Device Problem Fracture (1260)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

During the procedure, the end of the needle broke and the procedure could not be performed.Another device from the same model was used to complete the procedure with no consequences to the patient.

Manufacturer Narrative

One brk transseptal needle/stylet assembly was received for evaluation.The needle had been bent in multiple locations at the distal curve area; no visible fractures were noted.The formed curve of the needle was no longer consistent with specifications due to the damage.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 needle bend is consistent with not following the instructions for use.The cause of the reported needle fracture remains unknown.

Event Description

During preparation for the procedure, it was noted that the tip of the needle was damaged, and physically broke when it was shaped by hand.Another needle from the same model was used to continue the procedure.There were no consequences to the patient.

Event Description

During preparation, the needle broke prior to insertion into the patient.Another needle from the same model was used to start the procedure.There were no consequences to the patient.

Manufacturer Narrative

Corrected data: b5.

• 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: 17365039
• MDR Text Key: 319672832
• Report Number: 3008452825-2023-00319
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2023

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: Other
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 8625805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 07/21/2023; 09/07/2023
• Supplement Dates FDA Received: 07/21/2023; 09/06/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1