It was reported that during a vena cava filter placement procedure, the filter was left in place and attempted to be removed for a month, the snare was not hooked and allegedly could not be retrieved.It was further reported that the device has not been removed after an unsuccessful percutaneous removal procedure.Reportedly, the procedure was completed.There was no reported patient injury.
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H10: the catalog number identified in section d4 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 in d2 and g4.H10: 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.H11: section a: through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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