(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.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 risk during the use of this device.
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Related manufacturer reference 9680001-2016-00030, 3008452825-2016-00032, 3005188751-2016-00021, 3005334138-2016-00013, 3005334138-2016-00014.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Double transseptal punctures were performed and ablation was successfully performed on all four pulmonary veins and the cavotricuspid isthmus.At the end of the procedure, the patient became hypotensive and an echocardiogram revealed a pericardial effusion on the anterior side of the heart, for which a pericardiocentesis was performed and protamine was administered.Despite the pericardiocentesis, the effusion continued and the patient was transferred in stable condition for surgical repair of a perforation at the coronary sinus ostium.There were no performance issues with any sjm device.
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