Concomitant medical products: arctic front advance cardiac cryoablation catheter.Medtronic 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.This 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 of the patients represented in the article is male/64 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿clinical recurrence and electrical pulmonary vein reconnections after second-generation cryoballoon ablation.¿ heart rhythm2016;13:1852¿1857.Http://dx.Doi.Org/10.1016/j.Hrthm.2016.05.025.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following patient complication while using a cryoablation balloon catheter system: there was one (1) patient who experienced cardiac tamponade, which required pericardiocentesis.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.Further follow up did not yet yield any additional information.The status/location of the system is unknown.No further patient complications have been reported as a result of this event.
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