MAUDE Adverse Event Report: ABBOTT MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pfa atrial fibrillation procedure, a cardiac tamponade which required surgery to repair.After an initial venography with the non-abbott device (cordis mpa2), a staining phenomenon was noted on the roof of the left atrium and during a maneuver to cannulate the right superior pulmonary veins by rotating the agilis 13f sheath and advancing the non-abbott device (guidewire by cook medical rosen) with the volt catheter balloon inside the sheath.When the tamponade was observed, a pericardiocentesis was performed but the bleeding continued so cardiac surgery was done which revealed a perforation in the left atrial roof.The patient is now stable.It is thought that the mpa2 could have been responsible to scratch the roof of the atrium after which the agilis 13f sheath could have been pushed on the scratched tissue and creating a perforation.There were no performance issues with any abbott device.
Event or Problem Description
During a pfa atrial fibrillation procedure, a cardiac tamponade which required surgery to repair.After an initial venography with the non-abbott device (cordis mpa2), a staining phenomenon was noted on the roof of the left atrium and during a maneuver to cannulate the right superior pulmonary veins by rotating the agilis 13f sheath and advancing the non-abbott device (guidewire by cook medical rosen) with the volt catheter balloon inside the sheath.When the tamponade was observed, a pericardiocentesis was performed but the bleeding continued so cardiac surgery was done which revealed a perforation in the left atrial roof.It is believed that based on the location of the perforation, the event was caused by the transseptal puncture.The patient is now stable.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.The batch 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-1¿ XS TRANSSEPTAL NEEDLE, 98 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: 24497175
• Report Number: 3008452825-2026-00102
• Device Sequence Number: 17416237
• Product Code: DRC
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 11187032
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown