Concomitant medical products: 2af284 balloon catheter product event summary: the data files were returned and analyzed.The data files showed that 16 applications were performed with balloon catheter, 2af284 with lot number 00329, without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no indication of relation of adverse event to the performance and malfunction of the product.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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It was reported that after a successful cryo ablation procedure, pericardial effusion was evident through intracardiac echocardiography (ice) imaging.Measures were taken to optimize blood pressure and heart rate.Pericardiocentesis, open chest procedure, cardiopulmonary resuscitation (cpr), and blood transfusions were performed.The patient is deceased.The cause of death was cardiac tamponade.
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