It was reported through a clinical trial, that approximately twenty days post dialysis placement procedure in the right internal jugular vein approach, patient had an adverse event of clotted catheter.It was further reported that catheter was removed and exchanged.The current status of the patient is unknown.
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As the lot number for the device was provided, a review of the device history records 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.(expiration date: 05/2023).
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