Concomitant medical products: afapro28 balloon catheter.Product event summary: the data files were returned and analyzed.The data files showed at least three applications were performed with balloon catheter afapro28 with lot number 64818 on the date of the event without any issue.Clinical issues (cardiac tamponade, perforation, hypotension, and bradycardia)were encountered during the procedure.In conclusion the reported sheath was not returned for investigation.There is no indication of relation of adverse event to the performance of the cryo device.If information is provided in the future, a supplemental report will be issued.
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It was reported that during a cryo ablation procedure, the mapping catheter perforated the auricle of the heart.During this time, the balloon catheter remained inflated.An angiography was performed and a cardiac tamponade was observed.The patient's blood pressure and heart rate dropped and a temporary pacemaker was placed until the heart rate stabilized.The case was aborted and the patient was hospitalized for an extended amount of time for observation.No further patient complications have been reported as a result of this event.
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