The additional proglide device is filed under a separate medwatch report number. 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. The reported difficulties 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. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
It was reported that an arteriotomy closure of the left common femoral artery was attempted using a proglide device with a 6f sheath after an interventional peripheral procedure. Reportedly, no suture was present when the proglide plunger was removed. Another proglide device was used with the same results. A new proglide device was used to achieve hemostasis. There was no reported adverse patient sequela. There was no clinically significant delay in the procedure or therapy. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5