It was reported that during a cryo ablation procedure, difficulty was observed when engaging the pulmonary vein branches.The mapping catheter was replaced with a guidewire.Immediately after a freeze, a short asystole was observed and the patient was unresponsive.Additionally, severe arrhythmias were observed, and there was no measurable blood pressure.Resuscitation was then performed, and the case was aborted.Subsequently, a thoracotomy was performed which confirmed severe tamponade, and the bleeding could not be stopped completely.The patient was then transferred to a heart surgical center, under extracorporeal membrane oxygenation (ecmo).No further patient complications have been reported as a result of this event.
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Product event summary: the data files for the date of the event were returned and analyzed.The files showed eight injections were performed with the balloon catheter without issue.Additionally, no system notices were received.A clinical issue was encountered during the procedure.There was no indication of a product malfunction and no physical product returned for analysis.If information is provided in the future, a supplemental report will be issued.
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