SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM

Description of Event or Problem

I (ATTENDING VASCULAR SURGEON) WAS USING THE MERIT SURFACER DEVICE TO PLACE A TUNNELED CENTRAL LINE IN THIS PATIENT WITH AN SVC OCCLUSION. WE HAD PRE-PROCEDURE IMAGING WITH A CTV. THERE WERE TWO MERIT EMPLOYEES PRESENT, THE REGIONAL SALES REPRESENTATIVE AS WELL AS A CLINICAL EXPERT. THE DEVICE WAS DEPLOYED AS THEY DIRECTED (AND AS OUTLINED IN THE COMPANY'S DIRECTIONS FOR USE). THE PATIENT CODED IN THE OPERATING ROOM AND DIED. AUTOPSY IS PENDING, BUT I BELIEVE THERE WAS AN ARTERIAL GREAT VESSEL INJURY.