COOLTOUCH

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION BY THE PLANT.

Description of Event or Problem

CLINIC REPORTED TO TECHNICAL SUPPORT THAT A (B)(6) YEAR OLD FEMALE PRESENTED FOR ENDOVENOUS ABLATION FOR INCOMPETENT RIGHT GREAT SAPHENOUS VEIN (GSV). THE INCOMPETENT VEIN WAS MAPPED AND MARKED WITH ULTRASOUND. ACCESS WAS OBTAINED ABOVE THE LEVEL OF THE KNEE. APPROXIMATELY 19 CM OF THE VEIN HAD BEEN SUCCESSFULLY TREATED, LASER WAS SET TO 1 MM/SECOND AUTOMATIC WITHDRAWAL AND THE LASER TIP WAS CLEARLY VISUALIZED WITHIN THE VEIN. THE GUIDING LIGHT BECAME VISIBLE AT THE ACCESS POINT AND WHAT APPEARED TO BE THE LASER TIP POPPED OUTSIDE THE SKIN. INSPECTION OF THE LASER TIP REVEALED THE LASER FIBER HAD FRACTURED INSIDE THE PATIENT AND AN ESTIMATED 9-10 CM OF GLASS FIBER REMAINED WITHIN THE PATIENT'S SAPHENOUS VEIN. PATIENT WAS SENT TO AN INTERVENTIONAL RADIOLOGIST WHO PERFORMED AN ULTRASOUND AND THEN A PHLEBECTOMY OF THE REMAINING GSV ON (B)(6) 2019. WHILE REMOVING THE VEIN, THE LASER FIBER POPPED OUTSIDE THE VEIN INTO THE VASCULAR SPACE AND COULD NOT BE ACCESSED THROUGH THE INCISION, SO PATIENT WAS CLOSED AND FIBER LEFT WITHIN SAPHENOUS COMPARTMENT. SUBSEQUENTLY, THE PATIENT SAW A VASCULAR SURGEON AND HAD A CT SCAN ON (B)(6) 2019, LOCALIZING THE FIBER WITHIN THE VEIN. THE PATIENT WAS SCHEDULED FOR OPERATIVE PROCEDURE ON (B)(6) 2019 TO HAVE THE REMAINING LASER FIBER REMOVED BY VASCULAR SURGEON. IT WAS REPORTED BY THE CLINIC THAT THE PATIENT IS EXPECTED TO HEAL AND THAT SCARRING WILL BE LIKELY. ADDITIONAL INFORMATION SOLICITED.