It was reported through results of a clinical trial that nine months and twenty-six days post index procedure completion, the subject had adverse event obstructed catheter with fibrin sheath formation.It was further reported that the adverse event relationship to study device was possibly related which requires additional surgical intervention and so action was taken to remove the device.Reportedly, the catheter was removed.The procedure was completed exchanging another new catheter.The current status of the patient is unknown.
|
As the lot number for the device was provided, a review of the device history records is currently being 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.(expiration date: 11/2020).
|