The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, however, medical records were provided.Per review of the medical records, the investigation confirmed for malposition of device, migration and patient device interaction problem.Based upon the available information, the definitive root cause 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 malposition of device, patient device interaction problem, and migration.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the 58 year old male patient was not provided.
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