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. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related 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 an arteriotomy closure of a mildly calcified right common femoral artery was attempted using a proglide device with a 6f sheath after a diagnostic heart catheterization procedure. Reportedly, all steps were followed per the instructions for use (ifu); however, hemostasis was not achieved. A non-abbott device was used to achieve hemostasis. There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5