inforMED
InjuryHCS

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

Model number

NA

Catalog 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