The reported event was for a pericardial effusion and st elevation.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cardiac perforation and st elevation 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 manufacturing reference:3005334138-2018-00045, 3005334138-2018-00046, 2182269-2018-00030, 2182269-2018-00031.During paroxysmal atrial fibrillation ablation procedure, st elevation was noted and a pericardial effusion occurred.While in the waiting phase of the procedure, it was noticed that the patient had st elevation.After flushing fluids through all the lines, approximately 10 minutes later the st segment returned back to normal and a precautionary angiogram was performed with no abnormalities observed.After this, the pulmonary veins were checked for isolation which was successful and the case was concluded.During the post assessment, an echocardiogram was performed, which revealed pericardial separation pointing to a pericardial effusion at the left atrial side.A pericardial drain was placed and the patient is in stable condition and being observed.There were no performance issues with any abbott devices.
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