Related manufacturer reference: 2030404-2014-00030, 3005188751-2014-00036, 00038, 00040.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.A livewire duo-deca ep catheter was placed in the coronary sinus as a positional reference.An agilis nxt introducer, a sl1 introducer, and a non-sjm ice catheter were advanced into the right atrium.Two brk transseptal needles were used to perform two transseptal punctures, after which a non-sjm lasso catheter was placed in the left atrium to assist in geometry creation with the ensite navx system.After the geometry was completed, a safire blu duo ablation catheter was used to perform ablation around the pulmonary veins.While ablating in the septal region anterior to the right pulmonary veins, an increase in heart rate was noted.The non-sjm ice catheter revealed a pericardial effusion.A pericardiocentesis was performed; however, due to continued active bleeding, the pt was transferred to a surgery center for successful repair of an intra-atrial perforation.The physician alleged no performance issues with any sjm device.
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The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the lot number was unavailable.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known inherent risk during the use of this device in the heart.
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