InjuryDRC
BRK¿ Transseptal Needle, 71 cm Length
Received Jul 27, 2026 · Event occurred Jul 8, 2026
Report 3008452825-2026-00409 · MDR key 50008554
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
Not reported
- Cardiac Perforation
Narrative
Description of Event or Problem
During the MitraClip procedure for mitral regurgitation, a pericardial effusion was noted after transseptal puncture with a BRK needle. Transseptal puncture was performed with the BRK needle and prior to inserting the MitraClip devices, a pericardial effusion was noted by the echocardiographer. The procedure was stopped, and a pericardiocentesis was performed. The patient was stable after the procedure and there were no further adverse patient health consequences.