The patient was having a procedure for a left femoral endarterectomy.During the procedure, the probe was removed but with the balloon still inflated.The surgeon sets up the probe and asks to inflate the balloon.In view of the blood return (non-action of the balloon), the surgeon asks to deflate it in order to remove the balloon.Despite several tests, the probe did not deflate and it was impossible to remove it.Balloon was deflated with a scalpel blade and while performing this action, the femoral artery was stripped.As a result of the injury that occurred, an abdominal incision was required to perform a femoral bypass and resulted in a longer intervention for the procedure.
|
The device was not returned for investigation due to the patient having a transmittable disease.Therefore, we're unable to conclusively determine the root cause of the incident.Per the ifu, the following may occur: "in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, plaque, arterial dissection, and hemorrhage." we have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.
|