A visual, dimensional and functional inspection was performed on the returned device.The reported insufficient information (faulty hub/balloon) was confirmed as a side arm/hub leak.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported and noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported that the box of the 3.0x38 mm xience sierra stent delivery system had written "faulty hub, balloon" on the outside.Reportedly, the device had been used in the mid left anterior descending (lad) coronary artery.No adverse patient effects were reported and there was no reported clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a leak in the hub.
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