Description of Event or Problem · 1
A VENOUS CATHETER THAT HAD BEEN IMPLANTED IN THE LEFT SUBCALVIAN VEIN SEVERAL MONTHS BEFORE HAD BECOME NON-FUNCTIONAL, AND X-RAYS SHOWED THAT THE INTRAVENOUS PORTION OF THE DEVICE HAD EMBOLIZED INTO THE RIGHT SIDE OF THE HEART. RPTR WAS ASKED TO TRY TO RETRIEVE THIS PART OF THE DEVICE. THE CATHETER AND THE RESERVOIR TO WHICH IT WAS ATTACHED WAS IMPLANTED ON 2/8/94. THE DEVICE HAD APPARENTLY BEEN FUNCTIONING NORMALLY UP UNITL A FEW DAYS PRIOR TO ADMISSION. THE PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY ON 12/5/94 WHERE AN ATTEMPT WAS MADE TO RETRIEVE THE EMBOLIZED PORTION. A 10 MM "GOOSE NECKED" LOOP SNARE WAS USED TO GRAB THE DEVICE IN THE RIGHT ATRIUM. NO DIFFICULTY AT ALL WAS ENCOUNTERED IN SNARING THE DEVICE. THE DEVICE WAS RETRACTED PROXIMALLY DOWN TO THE 11F SHEATH THAT HAD BEEN INSERTED IN THE RIGHT FEMORAL VEIN FOR WHICH THE SNARE HAD BEEN INTRODUCED. UNFORTUNATELY, AS THE CATHETER AND SNARE WERE BEING WITHDRAWN FROM THE VEIN, THE SNARE CUT THROUGH THE CATHETER. THUS, THE LARGEST PORTION WAS RETRIEVED, BUT A SIGNIFICANT PORTION OF THE DEVICE EMBOLIZED BACK INTO THE HEART AND OUT INTO THE PULMONARY ARTERIES. SEVERAL MORE ATTEMPTS WERE MADE TO RETRIEVE THE EMBOLIZED PORTION. EACH TIME, THE DEVICE COULD EASILY BE SNARED. UNFORTUNATELY, EVERY TIME THE DEVICE WAS BROUGHT BACK TO THE GROIN IN AN ATTEMPT TO REMOVE IT FROM THE VEIN, THE SNARE CUT THROUGH THE DEVICE CAUSING EMBOLIZATION OF PIECES OF THE DEVICE ITSELF. THE PIECES OF THE DEVICE EMBOLIZED INTO THE PERIPHERAL BRANCHES OF THE LEFT UPPER LOBE PULMONARY ARTERY. AT THAT POINT, IT WAS IMPOSSIBLE TO RETRIEVE THE EMBOLIZED PORTIONS. THE PT AT THAT TIME WAS HEMODYNAMICALLY STABLE, AND NO DIFFICULTY AT ALL WAS ENCOUNTERED FROM THE SMALL EMBOLIZED PORTIONS. THE PROCEDURE WAS THUS STOPPED. THE PT IS BEING FOLLOWED CLINICALLY AND SO FAR HAS HAD NO PROBLEMS ALTHOUGH HE STILL HAS RETAINED PIECES. THE RETRIEVED RESERVOIR WAS EXAMINED, AND IT WAS FOUND THAT THE PROXIMAL PART OF THE TUBE PORTION OF THE CATHETER ITSELF WAS STILL ADEQUATELY SUTURED AND ATTACHED TO THE RESERVOIR AND THAT THE DISTAL PORTION OF THE TUBE OF THE CATHETER HAD BROKEN OFF. IT HAD APPARENTLY BROKEN OFF JUST AT THE POINT WHERE THE TUBE PORTION OF THE DEVICE GOES DEEP TO THE CLAVICLE AND THUS IS EXPOSED TO BENDING EFFECTS FROM NORMAL MOTION OF THE CLAVICLE. AFTER RPTR COMPLETED THE PROCEDURE, HE EXAMINED THE PART OF THE DEVICE THAT HAD BEEN RETRIEVED AND FOUND THAT THE PLASTIC THAT HAD BEEN USED TO MAKE THE DEVICE WAS EXTREMELY SOFT AND PLIABLE TO THE POINT THAT IT COULD BE EASILY TORN WITH VERY LITTLE EFFORT. THE TECHNIQUE THAT WAS USED TO RETRIEVE THIS DEVICE WAS THE STANDARD TECHNIQUE THAT AND THE SNARES WERE STANDARD COMMERCIALLY AVAILABLE PRODUCTS. RPTR HAS RETRIEVED A NUMBER OF DEVICES. THERE APPEARS TO BE SOME TYPE OF DEFECT IN THE MANUFACTURE OR IN THE MAKE UP OF THE PLASTIC COMPRISING THE DEVICE.