As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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It was reported that during a vena cava filter placement procedure via internal jugular vein for a patient diagnosed with risk of pulmonary embolism, the filter was allegedly could not go through the sheath.It was further reported that the delivery tube and sheath had unscrewed itself a little bit.Reportedly, the leg of the filter allegedly bent.The procedure was completed using another device.There was no reported patient injury.
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