Product event summary: the data files were returned and analyzed.The patient files showed at least seven applications were performed with balloon catheter afapro28 with lot 54293-170 without any issue on the date of the event.The clinical issue (tamponade, blood pressure drop) occurred during the procedure.The case was aborted under general anesthesia.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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