The device will not be returned as it was discarded. Investigation has not yet begun. 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 a common femoral vein was attempted with a proglide device using the pre-close technique via a 6f sheath prior to a percutaneous valve repair interventional procedure. Reportedly, there was no suture present when the plunger was removed. The sutures of two new proglide devices were successfully pre-placed. The sheath was upsized to a 14f and the percutaneous valve repair procedure was completed. Hemostasis was achieved with the pre-placed proglide sutures. There was no reported 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