MAUDE Adverse Event Report: ABBOTT MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; Trocar

Model Number	G407208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, a cardiac tamponade occurred requiring a pericardiocentesis.Transseptal puncture was performed under echocardiographic guidance, seemingly without difficulty.An advisor fl mapping catheter was placed in the left atrium.Sheath filtering on ensite was difficult.Geometry mapping began but the physician had significant difficulty navigating within the left atrium and decided to replace the catheter with a tacticath se ablation catheter.Upon introduction of the tacticath, impedance was elevated in certain areas (>300 ohms) and the geometry did not match the ct scan.The patient's blood pressure dropped.Transthoracic echocardiography revealed a significant pericardial tamponade.A pericardiocentesis was performed, the patient stabilized and was transferred to the intensive care unit.The physician alleges the brk needle caused or contributed to the tamponade.There were no performance issues with any abbott device.
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 incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: Trocar
• Manufacturer (Section D): ABBOTT 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): ABBOTT 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23645247
• Report Number: 3008452825-2025-00619
• Device Sequence Number: 13218830
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: (01)05414734205139(10)10999071(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/25/2025

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: G407208
• Device Catalogue Number: G407208
• Device Lot Number: 10999071
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 90 KG