As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive for failure to advance.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 dl900j vena cava filter allegedly experienced failure to advance and expansion failure.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
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