TRANSSEPTAL NEEDLE, BRK SERIES
Received Jun 12, 2026 · Event occurred Apr 16, 2026
Report 3008452825-2026-00334 · MDR key 25487338
Device
Generic name
Trocar
Manufacturer
Abbott MedicalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cardiac Perforation
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE BATCH RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. 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. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, A PERICARDIAL TAMPONADE OCCURRED DURING THE TRANSSEPTAL PUNCTURE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). PT: 2226. DEVICE: 2682. REF: MW5187653.