H6 - medical device problem code 2017 clarifier: failure to follow steps/instructions.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that femoral angiogram was not performed.It should be noted that the prostyle instructions for use (ifu) states: prior to deployment of the perclose prostyle device, perform a femoral angiogram to evaluate the access site for vessel size, calcium deposits, tortuosity, and for disease or dissections of the wall to avoid device cuff misses (device needles not engaging with the cuffs) and / or posterior wall suture placement and possible ligation of the anterior and posterior walls of the vessel.In this case, it is unknown if the absence of femoral angiogram contributed to the reported difficulty.The reported difficulty and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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