One used 6fr destination device was received for product analysis.The returned device was subjected to decontamination.After decontamination, the returned sheath and dilator were subjected to visual analysis.The luer of the crosscut valve assembly did not appear secured to the hub of the sheath.There was only approximately one turn of the luer onto the hub.By rotating the assembly clockwise, the luer fit became more secure.There were no other visual anomalies noted with the device.Microscopic pictures were taken of the luer to observe if any additional damage had been sustained which allowed the luer to loosen.No anomalies were found.At this time, it is unclear what contributed to the loosened luer if user handling led to the issue, or if there was difficulty packing the device.The ifu states that the user should "ensure that the valve and sheath are tightly connected." it appears that this was not followed.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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