BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Received Jun 12, 2026 · Event occurred May 27, 2026
Report 3008452825-2026-00335 · MDR key 25487576
Device
Generic name
Trocar
Manufacturer
Abbott MedicalModel number
G407209Catalog number
G407209
Lot number
11303637
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cardiac Perforation
Narrative
Description of Event or Problem
FOLLOWING COMPLETION OF A PVI PROCEDURE, A FOLLOW-UP EXAMINATION WAS PERFORMED, AND AN ULTRASOUND REVEALED A SMALL EFFUSION OVER THE RIGHT ATRIUM. THE PATIENT WAS MONITORED WITH NO ADDITIONAL INTERVENTION ADMINISTERED. IT WAS NOTED THAT THE TRANSSEPTAL PUNCTURE WAS DIFFICULT AND THE PATIENT HAD ABNORMAL CARDIAC ANATOMY. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.
Additional Manufacturer Narrative
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 TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.