Product event summary: the data files were returned and analyzed.The data files showed that seventeen applications were performed with the balloon catheter, 2af284 with lot 00437 without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no 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 following a successful cryo ablation procedure, a complication was noted by the anesthesia team.The patient's blood pressure dropped, cardiopulmonary resuscitation (cpr) was attempted, and was unsuccessful.The patient died.Incoming information indicated that the cause of death was cardiac tamponade.
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