It was reported through results of a clinical trial that two months and four days post index procedure, the subject had serious adverse event of clotted catheter and the relationship to study device was possibly related.It was further reported that, the subject had serious adverse event of exposed cuff catheter.The relationship to study device was possibly related and associated with device failure.Reportedly, the catheter was removed and the reason for removal was thrombosis.The procedure was completed by exchanging another catheter.However, 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: 05/2022).Device not returned.
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