DCS 18 2X4 HELICAL FILL
Received Nov 10, 2005 · Event occurred Oct 12, 2005
Report 1058196-2005-00373 · MDR key 646359
Device
Generic name
Cnv Dcs Coils
Manufacturer
Cordis Neurovascular, Inc.Model number
NACatalog number
635F00204
Lot number
13010886
Product problems
- Detachment Of Device Component
Patient
59 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS PT WAS UNDERGOING COIL EMBOLIZATION WITHIN THE CAVANOUS SINUS THROUGH INFERIOR PETROSAL SINUS APPROACH. THERE WERE NO CALCIFICATION AND VESSEL TORTUOUSITY. AFTER THE PHYSICIAN PLACED THE 4TH DCS COIL WITHIN THE CAVANOUS SINUS, HE PRESSURIZED THE SYRINGE AND CONFIRMED THE GAUGE WENT DOWN. AFTER THAT, WHEN HE PULLED THE DELIVERY TUBE, THE END OF THE COIL (ABOUT 5MM) REMAINED IN THE MICROCATHETER (MC). HE PUSHED THE COIL WITH THE GW AND COULD PLACE THE COIL INTO THE CAVANOUS SINUS. AFTER IT WAS NOTICED THAT THE GRIPPER SEPARATED FROM THE SYSTEM. IT'S POSSIBLE THAT THE PART REMAINED IN THE PT'S BODY, BUT COULDN'T BE CONFIRMED. THERE WAS NO REPORTED PT INJURY, THE PT WAS STABLE AND WAS DISCHARGED HOME SOON AFTER THE PROCEDURE.
Remedial action
- Other