Concomitant medical product: 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 patient or 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 has occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The gender of the baseline characteristics is male and the baseline age is 60 years old.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.Referenced article: pulmonary vein isolation cryoablation for persistent and long-standing persistent atrial fibrillation patients.Clinical outcomes from real word multicentric observational project, heart rhythm (2017), doi: 10.1016/j.Hrthm.2017.10.038.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following patient complications while using a cryoablation balloon catheter system: there were two (2) patients each, who experienced pericardial effusion and cardiac tamponade; all with unknown treatment/resolution.There were seven (7) patients who had ¿transient diaphragmatic paralysis (with fully recovery before hospital discharge.¿ there were four (4) patients who had a hematoma; one (1) patient each, who had an arteriovenous (av) fistula, or a femoral pseudo aneurysm.The status/location of the cryoballoon catheter system is unknown.No further patient complications have been reported as a result of this event.
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