The literature publication reported the following product performance issue during the ex vivo study of a cryoballoon ablation balloon and steerable sheath catheter: air bubbles were seen during the simulation of the ablation procedure.Of note, multiple manufacturers/multiple methods were noted in the article: radio frequency ablation and cryoballoon ablation.A silicone heart model was used for the procedure, and ¿all manipulations replicated the actual clinical procedures conducted at the hospital.¿.There were small and large air bubbles noted during the procedure: at the time of sheath flushing, and prior to the time of inserting the balloon into the sheath.It was also noted that the balloon was ¿massaged¿ in a saline solution to remove the air bubbles.The author concludes by indication, ¿air bubbles enter the la at specific times during rf catheter and cb ablation procedures; however, this intrusion can be reduced using several techniques and different conditions.¿.There was no patient involvement.Further follow up did not yet yield any additional information.
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