As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.However, medical record was received for evaluation.Therefore, the investigation is confirmed for the reported positioning problem and it is inconclusive for filter tilt, detachment and the retrieval difficulties.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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A review of the reported information indicates that model md800j vena cava filter allegedly experienced filter tilt, difficult to remove, detachment and positioning problem.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) female patient weighs (b)(6).
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