[1848947]
This event occurred in one patient on (b)(6) 2011. Acclarent's vp of medical affairs was promptly notified, and the following information from the acting physician was noted: the patient was a (b)(6) male who was undergoing balloon sinuplasty under conscious sedation. A 6x16mm solo pro balloon catheter was inserted and inflated to 12 atm pressure. When the balloon deflated, brisk bleeding was noted from the front wall of the sphenoid sinus. The patient was given a general anesthetic and intubated. It appeared as if the balloon had dilated the sphenoid sinus ostia and a small part of bone on the inferior aspect of the front face of the sphenoid injured a branch of the sphenopalatine artery, which traverses this area. The area was cauterized and the bleeding stopped. The physician then treated the frontal sinuses with the same balloon catheter successfully. There were no further events at the time of surgery. The patient has since had three serious nosebleeds from the same side. He is undergoing an evaluation for a bleeding disorder. Two blood transfusions were needed. The physician was well trained, and has performed several cases per month since 2007. Until this event, he has not had any event of this kind. He felt the acclarent balloon technology functioned correctly, and no malfunction had occurred. In addition, he felt that the bleeding occurred as a result of possible blood vessel injury from a piece of bone or coagulopathy (condition related to slow clotting/bleeding). The customer complaint rate for bleeding associated with acclarent technology from (b)(6) 2010 to (b)(6) 2011 has been noted as 0. 001%. No negative trend has been identified at this time. We will continue to monitor and trend this failure mode and will continue to update the file with any additional information and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: D, B5