G30-02 VIS-RX MICRO-IMAGING CATHETER

Additional Manufacturer Narrative

DURING PULLBACK TESTING ON CONSOLE 22F0109, THREE CATHETERS SHOWED PULLBACK FAILURE AND ABNORMAL NOISE, THOUGH NO CONSOLE ERRORS APPEARED. RETURNED CATHETERS SHOWED NO DAMAGE AND ALL FUNCTIONS WERE NORMAL; THE COMPLAINT COULD NOT BE CONFIRMED. ALL CATHETERS WERE PAST SHELF LIFE. INVESTIGATION CONCLUDED NO CATHETER DEFECTS WERE FOUND.

Description of Event or Problem

A STERILIZATION EXPIRED, UNOPENED, NEW CATHETER WAS USED AS A SAMPLE. IT WAS OCCURRED THAT WHEN PERFORMED CHECKING THE CATHETER OPERATION. WHEN PULLBACK OPERATION CHECKED WITH OCT_22F0109, PIM OPERATED NORMALLY, BUT CATHETER COULD NOT BE PULLBACK. AFTER THAT, AN ABNORMAL NOISE OCCURRED DURING ADVANCE. THERE WAS NO ERROR DISPLAYED ON THE CONSOLE MONITOR, AND THE REVIEW SCREEN WAS DISPLAYED AFTER THE PULLBACK. IT SEEMS THAT THE CONSOLE SIDE DOES NOT RECOGNIZE THAT THE CATHETER CANNOT BE PULLBACK AND THAT ABNORMAL NOISE IS OCCURRING (AND DEFECTIVE OPERATION). OPERATION CONFIRMED WITH 10 CATHETERS, AND DEFECTIVE SYMPTOMS OCCURRED WITH 3 CATHETERS: 2 IN 22E1004 AND 1 IN 22G1207. WHEN A CATHETER THAT WAS CONSIDERED TO BE DEFECTIVE WAS USED WITH OTHER CONSOLES (S/N:(B)(6)), DEFECTIVE SYMPTOMS DID NOT REPRODUCE AND THE PULLBACK WAS PERFORMED WITHOUT PROBLEMS.