AURYON ATHERECTOMY CATHETER

Additional Manufacturer Narrative

THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE(B)(4).

Description of Event or Problem

WHILE USING A 2.0 LASER CATHETER, THE LASER TIP BECAME DISLODGED FROM THE CATHETER. THE TEAM PULLED THE CATHETER OUT BUT THE TIP STAYED INSIDE THE PATIENT. THEY USED A BALLOON TO RETRIEVE THE LASER TIP. ADDITIONAL INFORMATION PROVIDED: THE CATHETER WAS VISUALLY INSPECTED PRIOR TO THE PROCEDURE AND WAS FOUND TO BE NORMAL. INTERNAL FLUSHING OF THE CATHETER AND THE GUIDEWIRE WITH HEPARINIZED SALINE SOLUTION WAS PERFORMED PRIOR TO GUIDEWIRE INSERTION. A 0.014" CSI VIPERWIRE GUIDEWIRE WAS USED. A CXI SHEATH WAS USED; HOWEVER, THE SIZE IS UNKNOWN. THE DISTANCE OF THE SHEATH FROM THE LESION IS UNKNOWN. THE LESION WAS IDENTIFIED AS IN-STENT RESTENOSIS (ISR) LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA); LESION LENGTH IS UNKNOWN. THE LASER UNIT USED WAS CONFIRMED TO BE EXL710 (SW VERSION 8.5). THE WORKING TIMES AT 50 MJ AND 60 MJ, AS WELL AS THE NUMBER OF PASSES AT EACH ENERGY LEVEL, ARE UNKNOWN. THE DAMAGE DID NOT OCCUR DURING REMOVAL FROM THE SHEATH, AS SEPARATION WAS NOTICED PRIOR TO REACHING THE SHEATH. THE DAMAGE WAS FIRST NOTICED EARLIER IN THE PROCEDURE WHILE THE GUIDEWIRE WAS BEING WITHDRAWN, BEFORE REACHING THE SHEATH. THERE WERE NO DIFFICULTIES REPORTED IN ADVANCING OR WITHDRAWING THE CATHETER PRIOR TO THE DAMAGE. THE CATHETER WAS REMOVED IN A STANDARD MANNER, AND THE SEPARATED PIECE WAS RETRIEVED USING A BALLOON. STENTS WERE PRESENT, BUT THERE WERE NO OVERLAPPING OR "KISSING" STENTS. PRESSURIZED SALINE WAS NOT CONTINUOUSLY INFUSED; THE CATHETER WAS FLUSHED AT THE BEGINNING AND INTERMITTENTLY DURING THE PROCEDURE. AN X-RAY WAS PERFORMED AT THE END OF THE PROCEDURE WITH NO SUBSTANTIAL FINDINGS.