The device was returned for analysis.The reported inflation problem and activation failure were 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 from this lot.The investigation was unable to determine a conclusive cause for the hub leak noted during return analysis; however, factors that may contribute to hub breaks include, but are not limited to, material damage, mishandling by user, and interaction between the hub and other device (stopcock, indeflator, etc.).The reported difficulties appear to be related to circumstances of the procedure as it is likely the noted hub break caused the reported inflation problems and activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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