It was reported that post-operatively to a cryo ablation procedure, a small amount of pleural effusion in the left chest and pericardial effusion were confirmed.Additionally, the patient experienced chest pain and fever.The patient's hospitalization was extended three days.The patient took colchicine for one week.It was noted the patient had a fever and chest pain ten days after discharge.St elevation was identified by electrocardiogram (ecg).It was noted that the patient restarted taking colchicine and was under remission; the symptoms did not recur.No further patient complications have been reported as a result of this event.
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Event summary: the patient data files showed at least fourteen applications were performed with catheter 2af284/23281-31 on the date of event; some applications were non-sustained, application number nine had temperature problem, flow low profile and fluctuation.Clinical issues (chest pain, fever, pericardial effusion) were encountered during the procedure and st elevation confirmed after one week.No product was returned for investigation.In conclusion, clinical issues (chest pain, fever, pericardial effusion and st elevation) were encountered during the procedure and post procedure.No indication of product malfunction.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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