MEDTRONIC DLP

Description of Event or Problem

A PATIENT UNDERWENT CABG WITH LEFT ATRIAL CATHETER INSERTED IN 2003. THE DEVICE WAS REMOVED THE NEXT DAY. DURING A FOLLOW-UP VISIT, A TRANSTHORACIC ECHOCARDIOGRAPHY (TEE) SHOWED A LEFT ATRIAL MASS, WHICH WAS CONFIRMED TO BE THE LEFT ATRIAL CATHETER. THE CATHETER BROKE AT MIDLINE PER PHYSICIAN. FLUOROSCOPY SHOWED THE DEVICE TO HAVE TORN OFF IN THE RIGHT SUBCOSTAL AREA. WHEN THE DEVICE WAS REMOVED, IT WAS BELIEVED THAT THE ENTIRE CATHETER HAD BEEN REMOVED. THERE IS NO COLORING OR MARKING ON THE TIP OF THE CATHETER THAT ALLOWS ONE TO IDENTIFY THAT THE ENTIRE CATHETER HAS BEEN REMOVED. ALSO, THE CATHETER CAN READILY BE STRETCHED FROM ITS LENGTH OF 12 INCHES TO ABOUT 18 INCHES WITHOUT BREAKING. FURTHERMORE, THE TIP IS NOT RADIOPAQUE SO IT CAN'T BE IDENTIFIED ON X-RAY. THE PATIENT WAS TAKEN FOR ELECTIVE SURGICAL REMOVAL 6 MONTHS LATER. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).