12FR GUIDING SHEATH

Description of Event or Problem

IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE CARDIOMEMS SENSOR, ACCESS WAS INITIALLY ATTEMPTED VIA THE PATIENT'S RIGHT FEMORAL VEIN. THIS WAS UNSUCCESSFUL, SO THE PHYSICIAN USED A SECOND ACCESS SITE AND ATTEMPTED THE LEFT FEMORAL VEIN, WHICH WAS SUCCESSFUL. A .018 (B)(6) STEELCORE WIRE WAS USED AND WHEN ATTEMPTING TO ADVANCE THE CARDIOMEMS DELIVERY CATHETER OVER IT, IT WAS NOT ABLE TO ADVANCE TO THE INTENDED AREA. THE CARDIOMEMS DELIVERY CATHETER WAS REMOVED AND A 5FR MULTIPURPOSE CATHETER WAS USED TO AID IN REPOSITIONING OF THE GUIDEWIRE. DURING THE REMOVAL OF THE MULTIPURPOSE CATHETER, THE 12FR SHEATH BECAME DISLODGED AND COULD NOT BE REINSERTED SUCCESSFULLY INTO THE LEFT FEMORAL VEIN. THE PHYSICIAN DETERMINED IT WOULD NOT BE SAFE TO CONTINUE; THE PROCEDURE WAS ABORTED. PHYSICIAN STATED THAT THE ISSUES ENCOUNTERED WERE CAUSED BY THE PATIENT'S UNIQUE ANATOMY. SITE WILL NOT BE MOVING FORWARD WITH CARDIOMEMS FOR THE PATIENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).