Description of Event or Problem · 1
CLINICAL HISTORY: PT IS A (B) (6) FEMALE WITH A HISTORY OF 99% STENOSIS OF A LEFT, SUBCLAVIAN STENT. PROCEDURE: A "GLIDE-WIRE" WAS INITIALLY USED TO PENETRATE THE OCCLUSION, FOLLOWED BY A QUICK CROSS (QC) CATHETER THE LENGTH OF THE OCCLUSION. UPON WITHDRAWING THE QC, THE PHYSICIAN DESCRIBED THE "DEVICE GOT CAUGHT ON SOMETHING", POSSIBLY A STENT STRUT. THE MD DISCOVERED THAT APPROX. 2" OF THE DISTAL END OF THE QC HAD BEEN TORN OFF AND REMAINED IN THE PT. THE "GLIDE-WIRE" WAS STILL IN PLACE AND THE FRACTURED DISTAL END WAS SUCCESSFULLY RETRIEVED WITH A 10MM MICRO-SNARE. PATIENT OUTCOME: THE PATENT DID NOT SHOW ANY ACUTE SIGNS OR DIFFICULTIES FOLLOWING THIS INTERVENTION. FAILURE ANALYSIS: THE .035 QUICK CROSS CATHETER WAS CAUGHT ON AN UNKNOWN OBJECT DISTAL OF THE PROXIMAL BAND CAUSING A TEAR RUNNING BETWEEN THE PROXIMAL AND MIDDLE BAND AS THE CATHETER WAS RETIRED WITH EXCESSIVE FORCE. THE CATHETER EVENTUALLY BROKE BECAUSE OF THE TEAR AND APPLIED FORCE LEAVING THE DISTAL SECTION (NOT JUST THE TIP) DISCONNECTED FROM THE CATHETER. THE DISCONNECTED DISTAL SECTION OF THE CATHETER WAS THEN RETRIEVED WITH A SNARE. THE RETURNED DEVICE WAS INSPECTED UTILIZING A S.E.M. (SCANNING ELECTRON MICROSCOPE) TO FIND ANY INDICATIONS OR MANUFACTURING ISSUES. NO MANUFACTURING ISSUES ARE APPARENT. THE ENCAPSULATED DISTAL BAND HAD NO SIGN OF ENCAPSULATION FAILURE. THE INVESTIGATION ALSO SHOWED PROPERLY SPACED DISTAL TO MIDDLE BANDS IN THE UN-STRETCHED PORTION OF THE DEVICE. THERE IS NO INDICATION OF THE MIDDLE OR PROXIMAL BANDS BEING DISLODGED OR MOVED FROM THEIR SWAGED POSITIONS.