During an atrial fibrillation procedure, when brockenbrough was performed by inserting a non-abbott rf needle (boston scientific) using a swartz braided transeptal guiding introducer, it stuck to the posterior wall and caused cardiac tamponade.An echocardiogram confirmed the accumulation of pericardial effusion, and the patient became hypotensive.After that, drainage was performed and the pericardial fluid was removed.The patient stabilized, however the procedure was discontinued.
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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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