(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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The 34 mm amplatzer septal occluder (aso) was placed in the atrial septum, where part of the aso prolapsed into the right atrium.The physician released the aso from the cable; however, he was not satisfied with the position.Therefore, he attempted to snare the aso with a 12 mm snare, which resulted in the aso embolizing to the right atrium (ra), followed by migration to the right ventricle (rv), and ultimately to the right ventricular outflow tract (rvot).The user attempted to snare the aso into the ra by the rij and rfv, but was unsuccessful.After 3 hours, attempts were abandoned and the patient had the aso surgically removed.The patient was reported to be in stable condition.
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