As the lot number for the device was not provided, a manufacturing review 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.
|
It was reported that approximately two years and ten months post port implant via the left subclavian vein, the patient allegedly deteriorated.Therefore, an x-ray imaging was performed which demonstrated catheter break.It was further reported that the distal catheter segment remained in patient's superior vena cava.Reportedly, the patient expired.
|