inforMED
InjuryDRC

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 Medical

Model number

407200

Catalog 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.