It was reported that during a cryo ablation procedure, when a competitor mapping catheter was inserted into the sheath, st elevation occurred, and the patient complained of chest pain and blood pressure declined.Nitroglycerin and neosynesine were administered were administered.It was noted that there possibly was an air embolism.Noradrenalin and neosynesine were administered.No air was observed through fluoroscopy, and a coronary angiography (cag) showed there was no stenosis.The case was completed with cryo.The following day post procedure, mri confirmed there were not any issues with the patient.No further patient complications have been reported as a result of this event.
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Product event summary: data files returned and analyzed.Data files showed that 10 applications were performed with a balloon catheter on the date of the event.A system notice had occurred indicating that the refrigerant delivery path was obstructed (#50012).In conclusion, a clinical issue occurred during the case and there was no indication of a product performance issue with the balloon catheter.The device was not returned for analysis/investigation.If information is provided in the future, a supplemental report will be issued.
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