MAUDE Adverse Event Report: ABBOTT MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	G407209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, a pericardial effusion occurred requiring surgical intervention.Following transseptal puncture, during device deployment, the patient became hypotensive.Echocardiographic imaging revealed the presence of a pericardial effusion.The patient required evaluation and management by the cardiovascular surgery team, who identified an injury at the left atrioventricular junction.The pericardial effusion was successfully managed, and the patient was subsequently transferred to the intensive care unit (icu) for close monitoring and further care.The patient remains hemodynamically stable, with no evidence of active bleeding.The patient has since recovered and was discharged.There were no alleged performance issues with any abbott devices.The physician reported challenges during the transseptal puncture due to suboptimal image quality of the transesophageal echocardiogram (tee) and to the patient's anatomical characteristics.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.An event of pericardial effusion was reported.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 perforation is a known risk during the use of this device.

• Brand Name: BRK-1¿ 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23420657
• Report Number: 3008452825-2025-00492
• Device Sequence Number: 13211054
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: (01)05414734205184(10)10772219(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/19/2025

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: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 10772219
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG