During an atrial septal defect procedure, the 22 mm amplatzer septal occluder (aso) prematurely detached from the 9f amplatzer torqvue 45 delivery system delivery cable (lot: 5248751) and embolized to the pulmonary artery.The aso was unable to be percutaneously removed and surgical intervention was required.Post operatively, the patient's condition worsened and the patient was placed on extracorporeal circulation in the intensive care unit.
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(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 incident could not be conclusively determined.
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