The other additional proglide is being 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. Based on the information reviewed, 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. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
It was reported that arteriotomy closure of a calcified common femoral artery was attempted using two proglide devices after an interventional angiogram procedure. Reportedly, when the plunger was removed, no sutures were attached, with both proglide devices. Another closure device was used to achieve hemostasis. There was no reported adverse patient sequela. There was no reported clinically significant delay in the entire procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5