TCI TUMESCENT CATHETER INVERSION SYSTEM
Received Jul 15, 2005 · Event occurred Jan 10, 2005
Report 1216828-2005-00021 · MDR key 622079
Device
Product problems
- Difficult To Position
Patient
UNKNOWN
- Surgery, prolonged
- Foreign body, removal of
Narrative
Description of Event or Problem
THE OLIVE CAME OFF INSIDE THE PATIENT LEG. THIS HAPPENED BECAUSE THE OLIVE WASN'T SEATED ON THE CONE AT THE END OF THE STRIPPER. THIS OCCURRED EITHER WHEN THE SURGEON DID NOT PULL THE VEIN UNILATERALLY, OR THE OLIVE WAS NEVER FULLY SEATED. THE OLIVE WAS SNAPPED ON CORRECTLY TO THE CABLE. UNFORTUNATELY, THE OLIVE CAN COME OFF IF THE SURGEON STRIPS HALF-WAY AND PULLS BACK A LITTLE, THIS CAUSES THE TAIL END TO UNSEAT AND POTENTIALLY NOT GO BACK ONTO THE CONE WHEN PULLED AGAIN. SINCE THE OLIVE ISNOT RADIO-OPAQUE THEY PULLED IN ANOTHER SURGEON THAT DOES ENDOSCOPIC VEIN HARVESTING. HE WENT IN WITH INSUFFLATOR AND SCOPE AND FOLLOWED THE STRIPPER UNTIL HE SAW THE OLIVE AND RETRIEVED IT. A ONE-HOUR DELAY WAS EXPERIENCED IN THIS PROCEDURE.