Product event summary: the data files were returned and analyzed.The data files showed that at least 10 applications were performed with balloon catheter, afapro28 with lot number 93895, without any issue on the date of the event.Clinical issues (bradycardia and sinus arrest, arrhythmia and dizziness) were encountered during the case.The balloon catheter 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 following a successful cryo ablation procedure, the patient entered into bradycardia and sinus arrest, and was dizzy.A temporary pacemaker was implanted.The patient entered sinus rhythm at a later point in time and was discharged as their issues resolved.No further patient complications have been reported as a result of this event.
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