Visual and functional inspections were performed on the returned device and the reported balloon leak/rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported/noted leak/balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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