Pt in procedure, left heart catheterization.Pt was found to have a blockage in the right coronary artery that need to be opened.The balloon that was used was not able to cross the lesion, however was found to have a hole in it.Before crossing the lesion we pull negative on the balloon, when this was done in this case there was blood return (which is not supposed to happen).Because the balloon was not able to cross the lesion it was taken out of the body.At this time, the balloon was attempted to be inflated and did not.Fda safety report id # (b)(4).
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