As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for evaluation, however, medical records were provided for review.The investigation of the reported event is confirmed for filter migration and material deformation and it is inconclusive for filter limb detachment and perforation of the inferior vena cava.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(4001-patient device interaction problem).
|
This report summarizes one malfunction.A review of the reported information indicated that model rf310f vena cava filter allegedly experienced detachment, perforation, material deformation and migration.This information was received from one source.This malfunction involved a patient with no consequences.The patient was a (b)(6) year old female and her weight was not provided.
|