The returned valve was patent.It met the requirements for reflux, pressure-flow and pre-implantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.The returned valve did not meet the requirements for leak testing due to a tear noted in the top of the reservoir.It is unknown how or when this damage occurred.The instructions for use that accompany the device caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ a review of the manufacturing records was not possible as no lot number was provided.All valves are 100% tested at the time of manufacture.
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