The returned valve was patent.It met the requirements for siphon, pressure-flow, and pre-implantation testing.However, the device did not meet the expectations for reflux testing.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve and may result in fluid reflux.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 also did not meet the requirements for leak testing due to a tear in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing 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 showed no anomalies.All valves are 100% tested at the time of manufacture.Approximately 121 cm of the peritoneal catheter was returned.The catheter was patent and met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.Approximately 2.5 cm of the snap catheter was returned.The catheter was patent and met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
|