Achieve mapping catheter medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.The gender of the baseline characteristics is male and the baseline age is (b)(6) years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: ¿safety and efficacy of cryoballoon ablation for paroxysmal atrial fibrillation in japan ¿ results from the japanese prospective post-market surveillance study.¿ doi: 10.1253/circj.Cj-16-0285.Circulation.2016.
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