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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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: miyazaki s, iwasawa j, kuroi a, iesaka y.Iatrogenic atrial septal defect after cryoballoon pulmonary vein isolation.Journal of cardiovascular electrophysiology.2015;26(9):1045-3873.(b)(4).
|
Miyazaki s, iwasawa j, kuroi a, iesaka y.Iatrogenic atrial septal defect after cryoballoon pulmonary vein isolation.Journal of car diovascular electrophysiology.2015;26(9):1045-3873.A journal article was reviewed which contained information regarding this patient's cryoablation procedure.Eight months after the procedure was done a "left to right interatrial shunt was captured on the ct [computed tomography] image." the patient did not have any atrial tachyarrhythmias nor any adverse events during the follow up period.No patient complications have been reported as a result of this event.
|