101025 BIOLITEC

PER THE DOCTOR: DURING AN ENDOVENOUS PROCEDURE, THE RADIAL HEAD OF THE FIBER BROKE OFF AND REMAINED IN THE PT NEAR THE SAPHENO-FEMORAL JUNCTION. IT WASN'T UNTIL THE FIBER WAS OUT OF THE LEG THAT THEY NOTICED THE MISSING RADIAL HEAD.

BIOLITEC IS WAITING TO SEE IF THE DEVICE CAN BE RETURNED FOR EVAL. WE HAVE REVIEWED OUR COMPLAINTS SINCE (B) (6) 2009 AND HAVE NOT HAD ANY ISSUES OF THIS NATURE AND WILL CONTINUE TO MONITOR ANY COMPLAINT TRENDS. A 30-DAY FOLLOW UP REPORT WILL BE FILED WITH THE FDA.