Procedure was endoscopic repair of type ia endoleak ia endovascular aortic aneurysm repair proximal aortic cuff and bilateral renal snorkeling, left iliac limb stenting, uv ultrasound, and left brachial artery exposure and repair.At the conclusion of the procedure the surgeon attempted to dilate the left renal artery using the balloon device, but when attempting to deflate, the balloon ruptured causing the tip to disintegrate when it was pulled back into the sheath.Once removed it was noted that the tip and distal marker were missing.Following examination the distal marker was located and removed.The balloon tip could not be accounted for and is not radiopaque, so could not be located despite attempts to do so.One of the items listed is the defective product.Because two of these items were on the sterile field, it was not possible to determine which item was defective since we could not find any lot number identifier on either product once out of the packaging.Second product information: same product identifiers: lot #5013994, exp date 05/30/2017.
|