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.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The overall baseline gender characteristics is male; the age of the patients was approximately 64 years old, and the baseline weight of the patients was 65 kgs.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: ¿periprocedural management of cardiac tamponade during catheter ablation for af under uninterrupted doac and warfarin.¿ jacc: clinical electrophysiology.2020; 6(7):786-795.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 a procedure using a cryoballoon ablation catheter system.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.There were patients who experienced cardiac tamponade, pericardial effusion, and bleeding.There was one (b)(6)-year-old male cryoballoon patient (patient #13), who also had a ¿tear¿ within the carina of the right pulmonary vein; which, according to the author was ¿caused by the sheath injury.¿ the surgery for this patient was "successful," however, the patient was transferred to a care center after discharge, due to decreased physical activity.Surgical intervention, including pericardiocentesis, and infusion of protamine, drains placed, and blood transfusions were performed as part of the treatment for these patients.The status/location of the cryoballoon catheter 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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