The returned valve was patent.The valve met the requirements for the valve flux test.It did not meet the requirements for leak, reflux, siphon, pressure-flow, and preimplantation testing due to damage to the delta chamber casing.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ there was proteinaceous debris on the interior and exterior of the valve.The instructions for use cautions, ¿the system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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