Exemption number e2019001.Visual and functional inspections were performed on the returned device.The reported loose or intermittent connection was not confirmed.However, a proxy indeflator, filled with water, was used to pressurize the balloon when fluid leaked out of the noted crack at the proximal end of the hub.In this case, it is possible that the inflation device was over torqued during attempts to connect to the hub of the device, resulting in the noted cracks, chipped off threading of the luer, leak and subsequently the reported loose or intermittent connection.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 from this lot.The investigation determined the reported difficulty appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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