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

Model Number 407200

Device Problem Difficult to Insert (1316)

Patient Problems Cardiac Perforation (2513); Thrombosis/Thrombus (4440)

Event Date 03/18/2024

Event Type  Injury  

Event 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.

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
• 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: 19003589
• MDR Text Key: 338902555
• Report Number: 3008452825-2024-00161
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 8664501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• 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
• Treatment: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Patient Outcome(s): Required Intervention