The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for perforation of the inferior vena cava, filter limb detachment, material deformation and retrieval difficulties.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.(device: 4001).
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This report summarizes one malfunction.A review of the reported information indicates that model rf048f vena cava filter allegedly unable to retrieve, detachment, material deformation and perforation.The information was received from a single source.One patient was involved with no reported patient injury.The female patient is (b)(6) years old.Weight of the patient was not provided.
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