MAUDE Adverse Event Report: Abbott 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	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the pfa procedure, a cardiac perforation was noted after ct surgery.After inserting the ice catheter, the physician noted that the patient had a thick, calcified superior limbus (~2.5cm) and ice imaging of the la was difficult to see because of it.Transseptal was performed with a brk needle through an agilis 13f sheath.During this process, the needle was difficult to visualize in the la.After taking the needle out and inserting a volt catheter, a 1 cm effusion was noted.No ablations were performed with the volt catheter and baseline was not performed yet.The chest was tapped and about 3.5l of blood was tapped and reinfused while preparing for surgery.During ct surgery, a 1cm hole was noted in the laa.The laa was sutured and the patient is now stable.

• Brand Name: BRK-1¿ 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 north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50071745
• Report Number: 3008452825-2026-00413
• Device Sequence Number: 13292342
• Product Code: DRC
• UDI-Device Identifier: 05414734205177
• UDI-Public: (01)05414734205177(10)11398261(17)290430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 407207
• Device Catalogue Number: 407207
• Device Lot Number: 11398261
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 233 LB