BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 3008452825-2026-00371 · MDR key 25778487
Device
Generic name
Trocar
Manufacturer
Abbott MedicalModel number
407200Catalog number
407200
Lot number
11382857
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR · Male
- Cardiac Perforation
Narrative
Description of Event or Problem
DURING AN ATRIAL FIBRILLATION PROCEDURE, A SMALL PERFORATION TO THE ROOF OF THE LEFT ATRIUM OCCURRED DURING TRANSSEPTAL PUNCTURE USING A 71CM BRK NEEDLE PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY GUIDANCE. APPROXIMATELY 5 MINUTES AFTER THE INITIATION OF MAPPING, THE PATIENT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE. A PERICARDIOCENTESIS WAS PERFORMED, AND CONTINUOUS DRAINAGE WAS CARRIED OUT FOR OVER AN HOUR, WITH AUTOTRANSFUSION PERFORMED BY REINFUSING BLOOD DIRECTLY VIA THE FEMORAL VENOUS ACCESS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE A THORACOTOMY WAS PERFORMED, ALLOWING IDENTIFICATION AND REPAIR OF THE LEFT ATRIAL PERFORATION. THE PATIENT IS STABLE. IT WAS NOTED THAT THE ALLEGED CAUSE OF THE PERICARDIAL EFFUSION WAS MANIPULATION OF THE BRK NEEDLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.