Medtronic received information of a pericardial effusion that occurred during a cryoablation procedure.The arctic front advance catheter was used to isolate the lspv, lipv and rspv and then the transseptal access was lost.The patient was diagnosed with a pericardial effusion following attempt at re-crossing the atrial septum after losing left atrial access.A non-medtronic rf ablation catheter (used for right atrial isthmus ablation for flutter) was advanced through the flexcath advance sheath and across the atrial septum before the pericardial effusion was diagnosed by intracardiac echocardiography.A pericardiocentesis was performed but continuous aspiration of pericardial fluid prompted the physician to call the operating room team.The patient was transferred to the operating room where the chest was opened and, according to the physician, the surgeon observed a hematoma around the right inferior pulmonary vein, but no bleeding.Cryoablation of the right inferior pulmonary vein was not attempted at any point during the procedure.No energy of any kind was applied to the ripv.Device 1 of 2, reference mfr report: 3002648230-2015-00090.
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