As the lot number for the device was not provided, a device history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
|
This report summarizes one malfunction.A review of the reported information indicated that model unk denali vena cava filter allegedly experienced positioning problem.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.
|