THE FIRST WIRE WAS EXAMINED AND FOUND INTACT, HOWEVER, COIL WAS BENT AND DEFORMED IN NUMEROUS LOCATIONS. THE WIRE BENDS INDICATE EXCESSIVE FORCES WERE APPLIED. THE SECOND WIRE WAS UNRAVELED AND BROKEN AT THE DISTAL JOINT. THE MICRO-INTRODUCER SHEATHS WERE ALSO EXAMINED: ONE SHEATH WAS FLATTENED AND THE SECOND HAD A .5CM SLIT FROM THE DISTAL END TOWARD THE PROXIMAL END, LIKELY CAUSED BY A SHARP OBJECT OR ANOTHER DEVICE BEING PULLED BACK THROUGH THE TIP. PRODUCTION RECORDS WERE REVIEWED AND NO OUT OF SPECIFICATION CONDITIONS WERE NOTED. RESULTS OF INVESTIGATION INDICATE THE RETURNED GUIDEWIRES WERE DAMAGED AS THE RESULTS OF SIGNIFICANT FORCES DURING OR AFTER THE PROCEDURE. THE TWO MICRO INTRODUCERS INDICATE DAMAGE FROM DEVICES BEING PULLED BACK THROUGH.
D
Patient 1
(B)(4). THE MICRO-INTRODUCER KIT WAS USED FOR EVLT ACCESS. ONCE THE GUIDEWIRE WAS IN PLACE, A LARGE BORE CANNULA WAS ADVANCED OVER THE WIRE TO ACCOMMODATE A FIBER. THE WIRE WAS THEN PULLED OUT AND NOTED TO BE UNRAVELLED. PATIENT HAD A REACTION - DEVICE WAS REMOVED AND A SECOND KIT WAS USED TO FINISH THE PROCEDURE. NO FURTHER COMPLICATIONS.