The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.The investigation determined the reported balloon rupture and leak appears to be related to operational circumstances of the procedure.It is likely that during advancement through the calcified lesion, the balloon outer surface became compromised and/or damaged resulting in the reported balloon rupture and the appearance of a leak and not allowing the balloon to properly inflate.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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