Following a successful cryo ablation procedure, a post-activation mapping procedure was performed with boston scientific¿s orion mapping catheter and rhythmia mapping system.The orion mapping catheter was inserted into the left appendage and subsequently the appendage was perforated.Following the post activation mapping procedure, a large effusion was seen forming under intracardiac echocardiography (ice).The patient underwent a pericardial tap, emergency surgery, and extended or prolonged hospitalization.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Ref report: mw5146773.
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