The same event: medwatch#3004721439-2021-00133.Investigation: visual inspection: no abnormalities were detected during the visual inspection.Permeability test: the permeability test showed that the progav 2.0 is permeable.The peritoneal catheter is not permeable.Computer control test: according to our results, we can confirm the presence of an accelerated outflow in the progav 2.0.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: after dismantling of the valve, clearly deposits were found in progav 2.0.Results: based on our investigation results, we can identify an accelerated outflow in the progav 2.0 and a blockage of the peritoneal catheter.We are assuming that the deposits detected have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.
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