The device was received.Visual and functional inspections were performed on the returned device.The reported tear in the balloon material was not confirmed.There were no anomalies noted to the balloon as reported, thus the reported complaint was not confirmed.However, it was noted that the top portion of the guide wire exit notch was stretched.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported tear in the balloon material since the complaint could not be confirmed during return analysis and limited information was reported.The stretching of the guide wire exit notch appears to have resulted from an interaction with the guide wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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