It was reported that during a cryo ablation procedure, a stain was still observed due to contrast media remained in the right inferior pulmonary vein (ripv).It was noted that during the cavo tricuspid isthmus ablation, fluoroscopy was checked to confirm balloon occlusion in the ripv, there was oozing in the pericardial sac.Additionally, resistance was noted when using the mapping catheter.The case was completed with cryo.Post operatively to the procedure, protamine was used to perform heparin reversal.The patient was placed under monitoring in the coronary care unit (ccu).A perforation in the ripv was noted, along with a "probable" mediastinal hematoma.A pericardial effusion was also observed.Further information received indicates that there was no therapeutic intervention reported and no treatment was performed for the hematoma.There were no additional patient symptoms reported.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 at least eight applications were performed with the balloon catheter without any issues or system notices on the date of event.Product analysis findings of the data files did not indicate a manufacturing related defect.In conclusion, clinical issues (pericardial effusion and cardiac tamponade) were encountered during the procedure.Also, there were no indications of product a malfunction.The physical device was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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