The catalog number identified has not been cleared in the u.S.But, it is similar to the denali vena cava filter products that are cleared in the us.The pro code for the vena cava filter products are identified.As the lot number for the device was provided, a device history review was performed.One denali filter, storage tube and a pusher catheter were returned to the manufacturer for inspection/evaluation.Investigation of the returned device confirmed advancement failure, detachment issue and kink.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model dl950f vena cava filter allegedly experienced failure to advance, material deformation and detachment.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.The age, weight and gender of the patient was not provided.
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