It was reported that immediately post cryo ablation procedure, during compression hemostasis treatment, the patient complained of discomfort and their blood pressure declined.Additionally, a pericardial effusion was confirmed via cardiac echo.It was noted that the pericardial effusion progressed to a cardiac tamponade.Drainage was subsequently performed, and a significant amount of blood was aspirated.Patient's blood pressure then recovered.No further patient complications have been reported as a result of this event.
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Product event summary: data files were returned and analyzed.Data files showed that 8 applications were performed with a balloon catheter on the date of the event with no issues.In conclusion, the reported clinical issues were not confirmed thorough data analysis.The device was not returned for analysis/investigation.If information is provided in the future, a supplemental report will be issued.
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