12 FR COOK SHEATH

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN WAS GETTING PUSH BACK OF THE CATHETER AND WIRE AND THE WIRE COULD NOT ADVANCE FURTHER INTO THE LEFT PULMONARY ARTERY. THE PHYSICIAN THEN ELECTED TO ABANDON THE RIGHT GROIN AND GET ACCESS VIA THE RIGHT INTERNAL JUGULAR VEIN. PATIENT¿S RIGHT NECK WAS PREPPED AND DRAPED. THE PHYSICIAN SUCCESSFULLY OBTAINED ACCESS TO THE RIGHT IJ WITH A 12FR COOK SHEATH. THE PHYSICIAN WAS ABLE TO GET TO THE LEFT PA WITH THEIR SWAN USING THE 0.25 SWAN WIRE. THE PHYSICIAN REPORTED THEY WERE STILL GETTING PUSH BACK. PHYSICIAN ELECTED TO GO TO THE RIGHT PULMONARY ARTERY AND PERFORMED AN ANGIOGRAM. THE PHYSICIAN UTILIZED A 5FR MULTIPURPOSE CATHETER AND 0.25 SWAN WIRE TO GET INTO THE TARGET VESSEL AS THE 0.018 WIRE WAS GOING DOWN THE WRONG BRANCHES. ONCE THE 0.25 WIRE WAS FURTHER INTO THE TARGET VESSEL, THE MULTIPURPOSE CATHETER WAS BACKED OUT AND THE SWAN WAS REINSERTED TO TAKE AN ADDITIONAL ANGIOGRAM. THE 0.25 SWAN WIRE WAS REMOVED AND THE 0.018 WIRE WAS INSERTED THROUGH THE SWAN, AND THE SWAN WAS BACKED OUT. THE DELIVERY SYSTEM WAS PREPPED AND THE INSERTED OVER THE WIRE AND DIRECTED UNDER FLUOROSCOPY TO THE TARGET LOCATION. THE SENSOR WAS DEPLOYED SUCCESSFULLY, AND CALIBRATION WAS COMPLETED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).