Manufacturing and quality control data: we have only received the product data without serial number.The product itself is not available for an investigation.Without a serial number it is not possible for us to retrace the complained product.Nevertheless, we can ensure that the progav 2.0 shunt system has a normal pressure range of 0 to 20 cmh2o.All parameters (opening pressure, reflux, tightness, adjustability and brake function) are inspected and signed during the manufacturing process.The progav 2.0 shunt system was manufactured by a qualified employee in may 2018.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav 2.0 shunt system is comprised of a progav 2.0 adjustable valve and a shuntassistant fixed pressure valve.The progav 2.0 valve has a normal pressure range of 0 to 20 cmh2o.The shuntassistant has a fixed pressure of 10 cmh2o.Before release, the progav 2.0 was pre-adjusted to a pressure setting of 5 cmh2o.Result: an investigation was not possible because no product was send for investigation.Without a detailed investigation, a meaningful analysis of the cause of the mentioned catheter disconnection is not possible.However, we can ensure that all our products are released for shipment only in a perfect condition due to a documented final check.All products of the delivery note met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further actions are required from our point of view.
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It was reported that a progav 2.0 shuntsystem (#fx432t) was implanted during a procedure performed on (b)(6) 2018.According to the complainant, the posterior catheter was disconnected.The patient returned sometime later and complained that she was "not feeling right".A shunt series was ordered and results showed that the distal catheter was fractured.When the surgeon examined the patient in the operating room, the shunt was exposed and the posterior catheter was noted to be completely disconnected (below the reinforced section distal to sa).After finding the distal break, the system including reservoir, progav, and shunt assistant was explanted.Another miethke product, fx817t was implanted instead.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.No further patient information are available.
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