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; however, medical records were provided for review.The investigation is confirmed for perforation, filter tilt, filter migration and retrieval difficulties.A definitive root cause for the reported event could not be determined.The device is labeled for single use.(b)(4).
|
This report summarizes one malfunction.A review of the reported information indicated that model dl900f vena cava filter allegedly experienced malposition of device, migration, difficult to remove and patient device interaction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient weight was not provided.
|