As the lot number for the device was provided, a manufacturing review will 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.The catalog number identified has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified.(expiry date: 06/2023).
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It was reported that during vena cava filter placement, the four legs of the filter were allegedly twisted and the filter placed in a tilted state.It was further reported that there was resistance felt during advancing the pusher.The filter was removed, and another device was used to complete the procedure.There was no reported patient injury.
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