BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Received Jun 30, 2026 · Event occurred Jun 19, 2026
Report 3008452825-2026-00350 · MDR key 25670103
Device
Generic name
Trocar
Manufacturer
Abbott MedicalModel number
G407208Catalog number
G407208
Lot number
11386946
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Great Vessel Perforation
Narrative
Description of Event or Problem
DURING A PULMONARY VEIN ISOLATION ATRIAL FIBRILLATION PROCEDURE, THE AORTA WAS PUNCTURED DURING TRANSSEPTAL PUNCTURE WITH A BRK NEEDLE RESULTING IN A PERICARDIAL EFFUSION. IT WAS NOTED THE AORTA WAS PUNCTURED. THE EFFUSION WAS DIAGNOSED USING ULTRASOUND. THE EFFUSION WAS DRAINED AND THE PATIENT WAS TAKEN INTO THE OPERATING ROOM FOR THORACIC SURGERY. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN ALLEGES A DIFFICULT TRANSSEPTAL PUNCTURE WAS THE CAUSE OF PERICARDIAL EFFUSION.