As the lot number for the device was provided, a device history review was performed.The sample was not returned to the manufacturer for inspection/evaluation but medical records were provided for review.Based on the investigation of medical records, filter migration was confirmed however, 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 ec500f vena cava filter allegedly experienced migration.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 (b)(6) year old male, the weight of the patient was not provided.
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