AURYON ATHERECTOMY CATHETER

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE: (B)(4).

Description of Event or Problem

A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN AURYON ATHERECTOMY CATHETER 2.0MM - HYDROPHILIC COATED. A 2.0 CATHETER BROKE AT THE TIP, FIBERS COMING OFF ON THE WIRE. THE DEVICE WAS THEN FULLY REMOVED, AND A SECOND 2.0 LASER FIBER WAS OPENED TO COMPLETE THE PROCEDURE. THE PROCEDURE PROCEEDED WITHOUT INCIDENT, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS PROCEDURE. ADDITIONAL INFORMATION PROVIDED: NO PICTURES OF THE CATHETER, TIP, OR BLADE WERE TAKEN. THE CATHETER WAS CHECKED BEFORE THE PROCEDURE AND WAS FOUND TO BE NORMAL. AN X-RAY WAS PERFORMED AT THE END OF THE PROCEDURE. NO RESISTANCE WAS NOTED DURING CATHETER REMOVAL THROUGH THE SHEATH. A TERUMO DESTINATION 6FR 45 CM SHEATH WAS USED. AN ASAHI GLADIUS MONGO 0.014 GUIDEWIRE WAS USED. THE CATHETER WORKING TIME AT 50 MJ AND 60 MJ IS NOT AVAILABLE. ONE PASS WAS PERFORMED AT 50 MJ AND ONE PASS WAS PERFORMED AT 60 MJ. THE LESION WAS LOCATED IN THE SFA WITH A LENGTH OF 120 MM. NO OVERLAPPING STENTS WERE OBSERVED. NO BROKEN STENTS WERE IDENTIFIED DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED VIA IV AND NOT THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A 1.7 AURYON CATHETER WITH GOOD RESULTS. THE PATIENT WAS UNAFFECTED BY THE CATHETER AND NO SIDE EFFECTS WERE OBSERVED. TOTAL LASING TIME: 1.3. HEP SALINE: PHYSICIAN DID NOT SPECIFY TO RUN DURING THE LASER PROCEDURE. DISCONNECTED TIP FOUND ON GW: FOUND ONCE CATHETER WAS REMOVED. CATHETER WAS NOT REMOVED FROM BODY TO FLUSH. NO ISSUE WITH ASPIRATION DURING PROCEDURE.