Visual and functional inspections were performed on the returned device.The reported leak was unable to be confirmed as the device was able to hold negative and positive pressure without any leaks noted.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 similar incidents and/or complaints reported from this lot.Potential factors that could cause this leak include, but are not limited to, manufacturing, damage to the bes, damage to the prep/inflation device, loose connections, or the technique used to prep the device.The investigation was unable to determine a conclusive cause for the reported leak.The noted kink on the stent, balloon and inner member likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device code 4008 was removed.
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