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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of the device.
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Related manufacturer reference number: 3008452825-2019-00630, 3005334138-2019-00807, 3005334138-2019-00808.During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.After a difficult transseptal access was obtained and multiple re-crossings of the septum occurred, mapping and ablation of the right lower pulmonary vein was started.As the mapping catheter was being manipulated, the patient became hypotensive.An echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
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