MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	407201
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a paroxysmal atrial fibrillation there was a cardiac tamponade.Access was gained through the left femoral vein.First, the inquiry 10 pole catheter was inserted, followed by an agilis sheath and brk needle.There was difficulty entering the left atrium via the septum, so ultrasound was used.Mapping of the left atrium was then completed with an advisor se catheter with the patient still in sinus rhythm.The tactiflex se catheter was then inserted, and ablation was started on the left pulmonary veins from the roof on the posterior wall.When the posterior side was completed, ablation was moved to the anterior side.The patient then became hypotensive, and weak, with slow responsiveness.A cardiac tamponade was seen on fluoroscopy and then was confirmed with ultrasound.A pericardiocentesis was performed and anti-heparin was administered.There was still blood accumulation, so the patient was intubated and underwent cardiac surgery for repair.The patient is stable.There were no alleged performance issues with the ablation catheter.All abbott recommendations and usage of the ablation catheter were according to the instruction for use.The physician alleges that the cardiac tamponade occurred either, during transseptal puncture, as it was needed to be attempted a couple times due to puncture difficulties, or during ablation of the left pulmonary veins on the posterior wall.The devices were discarded.
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 cardiac tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK-1¿ 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20436586
• Report Number: 3008452825-2024-00581
• Device Sequence Number: 8360319
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: (01)05414734205160(10)10421861(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/02/2025

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: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 10421861
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/13/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTIFLEX ABLATION CATHETER, SE.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown