It was reported that during a cryo ablation procedure, a pericardial effusion was observed via intracardiac echocardiography (ice).Additionally, the patient experienced hypotension and a perforation in the right ventricle.A pericardiocentesis was performed, and a significant amount of blood was drained from the pericardium, which resulted an increase in the patient's blood pressure.The case was then aborted, and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.
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Product event summary: the data files were returned and analyzed.The data files showed at least 10 applications were performed with balloon catheter 2af284 with lot number 59085 on the date of the event without any issue.Clinical issues (pericardial effusion, hypotension and perforation) were encountered during the case.The sheath was not returned for investigation.There is no indication of relation of adverse event to the performance of the product.If information is provided in the future, a supplemental report will be issued.
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