PERCLOSE
Received Feb 5, 2004 · Event occurred Feb 2, 2004
Report MW1031108 · MDR key 511454
Device
Generic name
Suture Delivery System
Manufacturer
Abbott LaboratoriesModel number
THE CLOSER S 6 FR.Catalog number
*
Lot number
09002-6H
Product problems
- Difficult to Remove
- Material Separation
Patient
59 YR
- Surgical procedure
- Foreign body, removal of
Narrative
Description of Event or Problem
PROCEDURE: STENT PLACEMENT, PROXIMAL RIGHT CORONARY ARTERY. AFTER THE SHEATH WAS REMOVED A PERCLOSE SUTURE DELIVERY SYSTEM WAS PLACED IN THE RIGHT FEMORAL ARTERY WITHOUT DIFFICULTY AND THE SUTURE WAS DEPLOYED. AFTER DEPLOYMENT THE SUTURE DELIVERY SYSTEM COULD NOT BE REMOVED. USING FLUOROSCOPY IT WAS DETERMINED THE DEVICE HAD SEPARATED INTO 2 PIECES. MULTIPLE ATTEMPTS WERE MADE TO MANUALLY REMOVE THE SUTURE DELIVERY SYSTEM. THE SUTURE WAS ABLE TO BE SUCCESSFULLY REMOVED BUT NOT THE DEVICE. THE DEVICE WAS THEN REMOVED BY CUTDOWN PROCEDURE IN THE OR. THERE WAS NO FLOW COMPROMISE TO THE EXTREMITY AND THE PT TOLERATED THE PROCEDURE.