The returned valve was patent.The valve met the requirements for valve flux, siphon, reflux, pressure-flow, pre-implantation, and leak testing.The laboratory personnel were able to adjust the valve normally.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Particulates were observed on the interior and exterior of the valve.It is not known how or when these particulates entered the valve.The instructions for use cautions that, ¿introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion or may also hold pressure/ flow controlling mechanisms open, resulting in overdrainage.¿ base misalignment was observed in the reservoir.It is unknown how or when this damage occurred.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¿¿ 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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