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The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock.
During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.