The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
It was reported that suture placement in the right common femoral artery was attempted with proglide devices, using the pre-close technique, via a 6f sheath prior to an abdominal aortic aneurysm (aaa) procedure. The suture of the first proglide device was successfully preplaced. Reportedly, the suture of the second proglide device failed to capture the artery. The suture of a new proglide device was successfully preplaced. The sheath was upsized to 10f and the aaa procedure was completed. Hemostasis was achieved with the successfully preplaced sutures of two proglide devices. There was no reported adverse patient sequela or clinically significant delay in the procedure or therapy. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5