As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned however, medical record was provided to the manufacturer for inspection/evaluation.Investigation of the medical record confirmed for perforation and material deformation.However, the investigation is inconclusive for filter limb detachment.Based on the available information, the definitive root cause 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 rf310f vena cava filter allegedly experienced detachment, perforation and material deformation.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.The patient was reported to be a 81 year old male who's weight was not provided.
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