Product event summary: the data files were returned and analyzed.The data files showed at least 12 applications were performed with afapro28 balloon catheter with lot 36531 without any issue on the date of the event.The clinical issues (hypotension, perforation and cardiac 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, the sheath "came off" in the right atrium and upon accessing the left atrium, the patient's blood pressure gradually dropped.A cardiac tamponade was observed.Medication was administered and drainage was performed.There was a possibility the sheath may have damaged the heart wall when attempting to access the left atrium.The sheath detached into the right atrium and the balloon catheter was removed.Left atrium access was performed using a dilator and a guide wire but aspiration could not be performed.The sheath was suspected to have hemostatic valve damage and was replaced.The case was completed with cryo and touch up was done with radiofrequency.The patient remains in the hospital and is recovering.No further patient complications have been reported as a result of this event.
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