No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.A device history record review was completed and documented that device met all specifications upon distribution.No further actions will be taken at this time.The hydragrip insert is a radiopaque clamp insert used for temporary local vascular control.If vascular control is lost, bleeding may occur and therefore delay the procedure.Per the ifu, care should be taken to ensure a firm grasp of the vessel when two compliant inserts are used, since traction is reduced and the possibility of slippage is increased.It is standard clinical practice to inspect all clamps and inserts prior to usage.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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