MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407211
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a pericardial effusion occurred which required a pericardiocentesis to stabilize the patient.Because the handle of the needle broke while performing transeptal puncture (the proximal part of the device outside of the patient, a pericardiac effusion occurred and a pericardiocentesis was performed to stabilize the patient.Because the patient was fine, the physician decided to continue the procedure with a 2nd needle.The procedure was completed and the patient is fine.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One brk transseptal needle was received for evaluation.The needle stopcock assembly was detached and not returned.Visual inspection revealed the needle had been bent in multiple locations.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the needle damage could not be conclusively determined.The cause of the cardiac perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 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: 21210671
• Report Number: 3008452825-2025-00034
• Device Sequence Number: 3943216
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: (01)05414734205153(10)10609742(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 10609742
• Was Device Available for Evaluation?: Yes
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown