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 referenced in the article.The baseline characteristics of the patients referenced in the article is gender/age is male/(b)(6).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: procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation.Heart rhythm.2016;13(2):424-432.(b)(4).
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Aryana amd, bowers mr, o'neill pg, et al.Procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation.Heart rhythm.2016;13(2):424-432.The literature publication reports the following patient complication: one (1) patient with a femoral pseudoaneurysm.The patient was discharged within one day of the procedure and was followed up for a minimum of three-six months.No further patient complications have been reported as a result of this event.
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