Device Dossier

CODA Balloon Catheter - Catheter, intravascular, occluding

Device Dossier for CODA Balloon Catheter - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor William A Cook).…

Intended purpose

To temporarily occlude large blood vessels to control hemorrhage from vessels distal to the balloon’s location or to expand and mold the sealing stent of endovascular stent grafts to the vessel wall.

Functional description

The balloon is prepared with saline/contrast mixture and all air is purged from it. The distal lumen is flushed with heparinized saline solution. Under fluoroscopy, the balloon catheter is advanced into the patient’s vasculature to the desired position over a .0.35” wire guide through a 14 Fr introducer sheath. The balloon is then inflated with saline/contrast mixture. After use, the balloon is deflated using a syringe and withdrawn.

TGA Public Summary