Related manufacturer reference 2030404-2014-00094, 2030404-2014-00095, 2030404-2014-00096, 3005188751-2014-00125.During a pulmonary vein isolation procedure, a cardiac tamponade occurred.An inquiry ep catheter was advanced into the coronary sinus.Transseptal puncture was performed with a brk transseptal needle and a therapy cool flex ablation catheter was advanced through an agilis nxt introducer to the left atrium.The patient was restless during the procedure and, after approximately two hours, became increasingly hypotensive and an echocardiogram revealed a cardiac tamponade.A pericardiocentesis was then performed, which stabilized the patient.There were 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 batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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