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.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 64 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: ¿midterm outcomes of catheter ablation for atrial fibrillation in patients with cardiac tamponade.¿ journal of arrhythmia.2019; 35:109¿120.Doi: 10.1002/joa3.12127.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 patients who experienced cardiac tamponade.Of note, multiple patients, multiple methods, and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.In one patient, cardiac tamponade occurred immediately after pulmonary vein isolation by cryoballoon and pericardiocentesis was performed; pericarditis occurred two days after catheter ablation and medications were administered.Then the pericarditis resolved, the patient was discharged.However, 33 days after catheter ablation, the patient experienced new-onset shortness of breath and presented to the emergency department.Increased pericardial fluid and inflow blockage was seen on the echo-cardiogram.The patient was diagnosed with ¿recurrent cardiac tamponade¿ and a repeat pericardiocentesis was performed.It was also noted, that st elevation on electrocardiogram (ecg) and increased serum c-reactive protein levels supported the diagnosis of recurrent pericarditis.There was also a patient with cardiac tamponade, which required pericardiocentesis.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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