Concomitant medical products: flexcath advance steerable sheath 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.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 serial/lot numbers.The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old.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: ¿left atrial volume index predicts arrhythmia-free survival in patients with persistent atrial fibrillation undergoing cryoballoon ablation.¿ journal of atrial fibrillation.2019; 12(2).If information is provided in the future, a supplemental report will be issued.
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The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system.There were three (3) patients experienced phrenic nerve palsy (pnp) which lasted beyond the end of the procedure; however, all of which completely resolved within six months.There was one (1) patient who developed a hematoma, and one (1) patient had a femoral pseudoaneurysm; for both patients, there was no indication of treatment/resolution.The status/location of the system is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
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