No device deficiency was reported.Pericardial effusion and cardiac tamponade are known potential adverse events documented in product labeling.During pre-procedure echocardiogram, a small effusion was noted at the left ventricular apex.The transeptal puncture was attempted 3 times, fully crossing the septum on the third attempt.During ablation of the right inferior pulmonary vein (ripv) the physician attempted to rotate the balloon catheter.During the attempt, the deflectable sheath introducer and balloon catheter coiled in the left atrium.The balloon was deflated and the sheath uncoiled by the physician which resulted in the catheter and sheath whipping to the superior aspect of the left atrium.The atraumatic tip of the catheter was outside of the sheath as described in the product labeling.On echocardiogram a worsening pericardial effusion was noted over the right side of the heart.Approximately 70cc of bright red blood was recovered before drainage slowed.This mdr 1225698-2019-00021 covers the sheath used in the procedure.A second mdr 1225698-2019-00020 will be submitted for the catheter used in the procedure.
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