Concomitant medical products: 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.The event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age characteristic is male/(b)(6) years old for the patients referenced in the article.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.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: ¿pulmonary vein isolation using a second-generation cryoballoon in patients with paroxysmal atrial fibrillation:one-year outcome using a single big-balloon 3-minute freeze technique.¿ doi: 10.1111/jce.13078.J cardiovasc electrophysiol,vol.Pp.1-6).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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