Product event summary: the data files were returned and analyzed.The patient files showed at least ten applications were performed with the balloon catheter 2af283 with lot 52684 without any issue.The clinical issues (pericardial effusion and hypotension) occurred during the procedure.There is no indication of relation of 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.
|