Product event summary: the data files were returned and analyzed.Patient files showed at least sixteen applications were performed with balloon catheter afapro28 with lot 56673, without any issue on the date of the event.The clinical issue (perforation, blood pressure drop and tamponade) occurred during the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.In conclusion, the physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
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It was reported that during a cryo ablation procedure, when an occlusion was attempted with the balloon catheter, the mapping catheter came out of the pulmonary vein (pv).The mapping catheter was reinserted into the pulmonary vein (pv).After multiple attempts of occlusion, a perforation was observed as contrast leaked into the endocardial side.The patients blood pressure declined.A pericardiocentesis was performed and fluid was drained.The case was completed with cryo.No further patient complications have been reported as a result of this event.
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