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

Model Number G407208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 09/20/2022

Event Type  Injury  

Event Description

During an atrial fibrillation procedure, the patient developed a pericardial effusion in the left atrium.A decapolar catheter was placed in the sinus, transseptal puncture was performed and a voltage map was done in the left atrium.The patient became hypotensive and an ultrasound revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.The physician thinks the needle went too far and too quick into the left atrium during transseptal puncture causing the effusion.

Manufacturer Narrative

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 effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• 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: 15476002
• MDR Text Key: 300582133
• Report Number: 3008452825-2022-00608
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122587
• 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: 10/06/2022

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
• Device Operator: Health Professional
• Device Model Number: G407208
• Device Catalogue Number: G407208
• Device Lot Number: 8218041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Patient Outcome(s): Required Intervention