Description of Event or Problem · 1
THE CORDIS OUTBACK LTD RE-ENTRY CATHETER IS DESIGNED TO BE USED IN THE CATH LAB SETTING TO BE MOVED PAST A CHRONIC TOTAL OCCLUSION (CTO) OF A VESSEL. IT CAN BE MOVED PAST THE OCCLUSION BY HUGGING THE VESSEL WALL AND THEN BE CORRECTLY ORIENTED UNDER FLUORO BY ROTATION SO THAT AN INTERNAL CANNULA CAN BE POSITIONED IN THE VESSEL'S LUMEN. A GUIDEWIRE CAN THEN BE PASSED THROUGH THE CANNULA INTO THE LUMEN PAST THE CTO AND THEN THE CATHETER CAN BE WITHDRAWN. THE GUIDEWIRE THEN ACTS AS THE GUIDE FOR SUBSEQUENT VASCULAR DEVICES LIKE ANGIOPLASTY BALLOONS AND STENTS FOR TREATING THE OCCLUSION. IN THIS CASE, A 2.5CM PORTION OF THE TIP OF THE CATHETER BECAME SEPARATED FROM THE MAIN CATHETER BODY, SEVERED SOMEHOW, EXPOSING THE TIGHTLY-WOUND WIRE IN THIS PORTION WHICH NORMALLY ALLOWS THE TIP TO HAVE FLEXIBILITY BUT ALSO STIFFNESS WHEN IT IS BEING ORIENTED AS DESCRIBED ABOVE. THIS HAPPENED IN THE VICINITY OF WHERE THE CANNULA EMERGES FROM THE SIDE OF THE CATHETER BUT IT IS NOT KNOWN IF THIS IS SIGNIFICANT. THE TIGHTLY-WOUND WIRE THEN BECAME STRETCHED OUT WHEN STAFF, KNOWING THAT THE CATHETER HAD FAILED, WITHDREW IT. THE TIP THEN HAD TO BE RETRIEVED WITH AS SNARE.====================== MANUFACTURER RESPONSE FOR CATHETER, OUTBACK RE-ENTRY CATHETER (PER SITE REPORTER)======================THEY HAD A LIST OF TWENTY QUESTIONS THAT THEY WANTED ANSWERED BY THE DOCTORS. THE QUESTIONS WERE ANSWERED AND RETURNED VIA E-MAIL.