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

Model Number	407200
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: 3005334138-2023-00547.During an atrial fibrillation ablation case, while preparing for the transseptal puncture, resistance was noted when inserting the brk needle into the sheath and the needle could not be advanced.The sheath was replaced but the issue was not resolved.The sheath was replaced a second time but the issue still persisted, and it was noted that the needle punctured the long sheath and dilator.The sheath and needle were both replaced and the issue was resolved.The procedure was completed successfully with no adverse consequence to the patient.The stylet was not used and the needle was reshaped.
Additional Manufacturer Narrative
One brk transseptal needle/stylet assembly was received for evaluation.The needle had been bent at the distal end.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.Instructions for use (ifu) states, ¿do not alter this device in any way.¿; the 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.
Event or Problem Description
Related manufacturing reference: 3005334138-2024-00005, 3005334138-2023-00547.
Additional Manufacturer Narrative
Udi related data quality updates only.Additional information: d4, g3, h2, h11.

• Brand Name: BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18247593
• Report Number: 3008452825-2023-00544
• Device Sequence Number: 17919375
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: (01)05414734205092(10)8690001(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K072278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 8690001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 07/10/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/10/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL0; SWARTZ BRD TRNS INTRO 8.5F 63CM-SL0; SWARTZ BRD TRNS INTRO 8F 63CM-SL0
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG