Description of Event or Problem · 1
PATIENT IS A FEMALE WITH TETROLOGY OF FALLOT, PULMONARY ATRESIA AND HISTORY OF PULMONARY ARTERY STENOSIS/HYPOPLASIA. PATIENT HAS UNDERGONE MULTIPLE CARDIAC CATHETERIZATIONS AND SURGERIES SINCE BIRTH. ON THIS DAY, THE RIGHT PULMONARY ARTERY UNDERWENT STENT MANIPULATION. A 10 MM STENT WAS POSITIONED IN THE AREA OF THE STENOSIS AND EXPANDED. THIS WAS FOUND TO BE TOO SMALL. THE STENT WAS DILATED WITH A LARGER BALLOON AND UPON RETRACTING BALLOON BACK INTO THE SHEATH, THE STENT CAME BACKWARDS INTO MAIN PULMONARY ARTERY. A SECOND STENT WAS PLACED OVER THE FIRST TO STABILIZE IT. WHEN ATTEMPTING TO EXPAND THIS STENT WITH 15 MM Z MED BALLOON BROUGHT UP TO 8 ATM, THE BALLOON RUPTURED. THE BALLOON WOULD NOT COME INTO THE LONG SHEATH. IT WAS THEN DECIDED TO RETRACT THE SHEATH AND BALLOON BACK TOWARD THE FEMORAL VEIN. THE LONG SHEATH CAME OUT OF THE BODY BUT WHEN THE BALLOON CAME OUT, THE TIP WAS MISSING. THE SHORT SHEATH IN THE GROIN WAS USED TO INJECT CONTRAST AND SHOWED THE MISSING PART OF THE BALLOON TO BE IN THE EXTERNAL ILIAC VEIN. ATTEMPTS TO RETRIEVE WITH A SNARE WERE UNSUCCESSFUL. A BIOTOME WAS USED TO GRAB THE RETAINED PIECE AND BRING IT INTO THE FEMORAL VEIN BUT IT COULD NOT BE TAKEN OUT. A VENOUS CUTDOWN WAS DONE AND THE PIECE WAS SUCCESSFULLY REMOVED. PATIENT ADMITTED TO ACUTE CARE UNIT FOR OBSERVATION AS ORIGINALLY PLANNED. PATIENT DID WELL OVERNIGHT AND WAS DISCHARGED HOME THE NEXT DAY. THE B BRAUN REPRESENTATIVE WAS CONTACTED AND IS TO COME AND PICK UP THE BALLOON. THE CATHETERIZATION LAB IS CONTACTING THE QUALITY DEPARTMENT OF THE MANUFACTURER REGARDING THIS EVENT.