MAUDE Adverse Event Report: Abbott Medical BRK-1¿ Transseptal Needle, 71 cm Length; Trocar

Model Number	407201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, a pericardial effusion was noted while using a brk needle.While attempting transseptal puncture, it was aborted due to significant atrial anatomical distortion from previous cardiac surgery.The pericardial effusion was noted during ablation of the cavotricupsid isthmus.A pericardiocentesis was perform with 120 ml of blood drained.The patient stabilized with no growth of the effusion.The patient remained stable with no complication after the pericardiocentesis.

• Brand Name: BRK-1¿ 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 ; +1(651)756-5400
• MDR Report Key: 50330766
• Report Number: 3008452825-2026-00455
• Device Sequence Number: 5356734
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: (01)05414734205160(10)11249046(17)290131
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/17/2026

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: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 11249046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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 Sex: Unknown