Description of Event or Problem · 1
SAME CASE AS MFR REPORT #: 3005099803-2008-04593, -04595. IT WAS REPORTED THAT DURING A TRACHEOBRONCHIAL STENTING PROCEDURE THERE WERE DEPLOYMENT DIFFICULTIES WITH THREE ULTRAFLEX STENTS. IT WAS REPORTED THAT THE PHYSICIAN SELECTED AND POSITIONED THE FIRST STENT (MODEL: 6906) AND ASKED THE NURSE TO DEPLOY THE STENT. THE NURSE BEGAN PULLING THE STRING AND FELT RESISTANCE. THE NURSE CONTINUED PULLING WITHOUT SUCCESSFUL UNRAVELLING OF THE THREAD. THE NURSE REPORTEDLY PULLED HARDER PER THE PHYSICIAN'S REQUEST AND THE CATHETER BUCKLED AT THE POINT WHERE THE THREAD FROM THE END OF THE STENT ENTERS THE CATHETER AS IT UNRAVELS. THE FIRST STENT WAS REMOVED AND ANOTHER STENT OF THE SAME SIZE AND LOT NUMBER WAS ATTEMPTED WITH THE SAME RESULT. THE SECOND STENT WAS REMOVED AND A THIRD STENT OF ANOTHER SIZE WAS ATTEMPTED, AGAIN WITH THE SAME RESULT. ON THE THIRD ATTEMPT, IT WAS REPORTED THAT MORE FORCE WAS APPLIED TO THE SUTURE AND IT SNAPPED, BEGINNING DEPLOYMENT OF THE STENT. THE PROCEDURE WAS STOPPED AND WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS; HOWEVER, THE PATIENT STILL REQUIRES A STENT.