The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.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.
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It was reported that during a recanalization procedure, the device allegedly got stuck and the wire allegedly fractured.It was further reported that the catheter, guidewire and the sheath was removed.Reportedly, the aorta was allegedly perforated which was found upon computed tomogrphic examination.The current status of the patient was unknown.
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