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 Codes	Cardiac Perforation (2513); Thrombosis/Thrombus (4440)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturing ref: 3005334138-2024-00108.During an atrial fibrillation procedure, a sheath was fractured, and a tamponade and thrombus occurred requiring a pericardiocentesis.After inserting the sheath into the patient, there was difficulty passing the transseptal needle.The sheath and needle were removed, and it was noted that the sheath was fractured.The sheath was replaced and a new transseptal puncture was attempted.However, a tamponade was then noted in the right atrium close to the septum.It was also noted that the sheath was not fixed well to the septum.The thrombus was seen through the transesophageal echocardiogram where the procedure was interrupted.A pericardiocentesis was performed, stabilizing the patient.The patient was then taken to the icu for follow-up.A transesophageal echocardiogram was performed before the procedure, but no thrombus was noted.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11 the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported sheath fracture, tamponade, and thrombus could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19003589
• Report Number: 3008452825-2024-00161
• Device Sequence Number: 13125929
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 407200
• Device Lot Number: 8664501
• Was Device Available for Evaluation?: No
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown