It was reported that during a recanalization procedure via the right sfa, the device was advanced to the left side of the bifurcation.Upon reaching the destination, the device allegedly failed to advance.After a few times trying to advance the device, the catheter was removed and the head of the device was noted to be detached from the catheter.There was no reported patient injury.
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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 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: 07/2024).
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