Visual and dimensional analysis was performed on the returned device.The reported deformation under compressive stress and failure to advance was not able to be confirmed due to the condition of the returned device.However, the guidewire exit notch was noted to be torn and stretched distally for a length of 1.5 millimeters.Based on the information received and analysis of the returned device, the investigation was unable to determine a cause for difficulties encountered.It may be possible that, after encountering resistance in the attempt to cross the lesion, the device was damaged.Furthermore, during removal, the dragonfly may have gotten inadvertently caught on the guidewire.The stretched and torn guidewire exit notch suggests that the guidewire and catheter were likely spread apart during removal.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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