MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	407207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation / atrial fibrillation ablation procedure, an effusion occurred.There were no difficulties obtaining venous access or placing the cs catheter or mapping the right atrium.While preparing to access the left atrium through transseptal access, the physician noted the patient had a thick septum which was confirmed via ice.Transseptal access was attempted multiple times and although access was obtained with the brk-1 needle, the introducer could not be advanced.The introducer eventually advanced and a small effusion was noted post transseptal access.The case then proceeded with a map of the left atrium and then ablation.An echo tech came in multiple times throughout the procedure to monitor the effusion.The left pulmonary veins and part of the posterior wall were isolated when the effusion became larger and the physician elected to abandon the case.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any abbott devices.The physician felt the effusion occurred during transseptal access and giving heparin during the procedure caused enlargement of the effusion.He also indicated, this was anatomy related.
Additional 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-1¿ 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14166427
• Report Number: 3008452825-2022-00386
• Device Sequence Number: 20089737
• Product Code: DRC
• UDI-Device Identifier: 05414734205177
• UDI-Public: 05414734205177
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 407207
• Device Catalogue Number: 407207
• Device Lot Number: 8325559
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 114 KG