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 an arteriotomy closure of the right common femoral artery was attempted using a proglide device with a 7f sheath after a percutaneous coronary intervention procedure. Reportedly, when attempting to depress the plunger, the plunger returned it its original position. It was depressed again but same issue occurred. A third attempt was made but same issue occurred. The device was removed, and 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