Related manufacturer reference 3005334318-2014-00014, 3005188751-2014-00153, 3005188751-2014-00155.Following an atrial fibrillation ablation procedure performed on a patient with complicated cardiac anatomy, a pericardial effusion occurred.After the ablation procedure was completed, the patient became hypotensive and an echocardiogram revealed a pericardial effusion originating from the left atrium.A pericardiocentesis was performed, which stabilized the patient, and no further intervention was required.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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