TARGET 360 ULTRA 5MM X 15CM

Description of Event or Problem

IT WAS REPORTED THAT DURING CORONARY ARTERY FISTULA PROCEDURE, PLANNED FOR COIL EMBOLIZATION. AFTER DELIVERING THE GUIDING CATHETER TO THE TARGET POSITION VIA THE RADIAL ARTERY, THE PHYSICIAN DELIVERED THE MICROCATHETER TO THE FISTULA OPENING. A STRYKER COIL WAS DELIVERED, POSITIONED, AND SUCCESSFULLY DETACHED. THE PHYSICIAN THEN DELIVERED AN ADDITIONAL COIL. AFTER FLUSHING, DELIVERY WAS INITIATED WITH NO RESISTANCE. AFTER INSERTING, THE PHYSICIAN WAS DISSATISFIED WITH THE RESULT AND ATTEMPTED TO REPOSITION THE COIL 3 TIMES, STILL UNSATISFACTORY. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE SUBJECT COIL BUT FOUND IT HAD ALREADY DETACHED AND COULD NOT BE RETRIEVED. ANGIOGRAPHY CONFIRMED THE SUBJECT COIL HAD NOT MIGRATED. THE PHYSICIAN THEN WITHDREW THE DELIVERY WIRE, AND AFTER TAKEN OUT IT WAS FOUND A METAL WIRE CONNECTED AT TIP OF THE DELIVERY WIRE. THE PHYSICIAN THEN USED COILS AND A MICROCATHETER OF ANOTHER BRAND TO CONTINUE INSERTING UNTIL SATISFIED, THEN CONCLUDED THE PROCEDURE. AFTER THE PATIENT WENT BACK TO WARD, THE NURSE DISCOVERED A METAL WIRE AT THE RADIAL ARTERY OCCLUSION AREA (EXTERNAL THE SKIN). FOLLOWING ANGIOGRAPHY REVEALED A WIRE-LIKE STRUCTURE EXTENDING FROM CORONARY ARTERY TO THE RADIAL ARTERY. THE PHYSICIAN ASSESSED THAT THE WIRE-LIKE STRUCTURE WOULD NOT CAUSE HARM TO THE PATIENT, SO THE EXTERNAL PORTION WAS CUT OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.