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	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pfa procedure with a volt catheter, the patient became hypotensive and ultrasound revealed a pericardial effusion in the right ventricle.A pericardiocentesis was performed, however the patient was transferred to another hospital for surgery.The physician stated that the event was due to a difficult transseptal puncture.Transseptal was performed with a swartz sheath and brk needle.Difficulties were experienced due to the patient's specific anatomy.The guide was used to change to an agilis sheath but transseptal was lost.Transseptal puncture was about to be performed with the agilis sheath and a new brk needle, however it was advised to perform the puncture with the swartz sheath and the brk needle instead.Ablation started, however, the perforation was then noted and a pericardiocentesis and surgical intervention was performed.The patient is stable and there were no alleged performance issues with any abbott devices.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.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 perforation is a known risk 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25273583
• Report Number: 3008452825-2026-00271
• Device Sequence Number: 13053279
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: (01)05414734205139(10)11256373(17)290131
• 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): 05/25/2026

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: G407208
• Device Catalogue Number: G407208
• Device Lot Number: 11256373
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2026
• 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; Life Threatening
• Patient Sex: Unknown