The device was not returned for analysis.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 of the reported lot revealed no other complaints.Based on the information provided, a conclusive cause for the pinhole leak could not be determined.It may be possible that the balloon became damaged during removal of the protective sheath or due to interaction with associated devices during preparation; 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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