It was reported that following a cryo ablation procedure that was completed with cryo, the patient experienced chest pain, and a pericardial effusion was noted.It was noted that during the procedure, an electrophysiology (ep) catheter was used to create a cavo-tricuspid isthmus (cti) block line.The patient's hospitalization was extended.The patient is noted to be stable at this time.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 that at least 8 applications were performed with balloon catheter, 2af284 with lot number 06419, and 9 applications with electrophysiology catheter, 239f3 with lot number 59484, without any issue on the date of the event.Clinical issues were encountered during the case.The balloon catheter was not returned for investigation.There is no indication of a product malfunction related to the adverse event.If information is provided in the future, a supplemental report will be issued.
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