OUTBACK ELITE RE-ENTRY CATHETER

Additional Manufacturer Narrative

FIVE IMAGES WERE RECEIVED. IMAGES SHOW AN UNRAVELED CTO CATHETER WHICH WAS KEEP INTACT BY THE NITINOL WIRE. THE LAST IMAGE SHOWS THE CATHETER COMPLETELY ASSEMBLED. A GUIDEWIRE IS ALSO SHOWN ON THE IMAGES. REVIEW OF LOT 17438707 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Additional Manufacturer Narrative

THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

DURING AN INTERVENTIONAL PROCEDURE IN THE SFA WITH AN OUTBACK ELITE 120CM RE-ENTRY CATHETER, THERE WAS DIFFICULTY GOING OVER THE AORTIC ARCH AND THE TIP UNRAVELED DURING ADVANCEMENT BUT REMAINED ON THE DEVICE BECAUSE THE NITINOL WIRES HELD THE TIP TOGETHER. IT WAS REMOVED AD WAS STILL ATTACHED TO THE DEVICE. PROCEDURE WAS DISCONTINUED. PATIENT IS FINE AND WILL BE REFERRED FOR SURGERY AT A LATER DATE. THE DEVICE WILL BE RETURNED. THE PHYSICIAN WAS TREATING THE SFA AND WAS HAVING TROUBLE GOING OVER THE ARCH AND MULTIPLE WIRES USED. ACCESS WAS VIA THE RIGHT GROIN WITH A 7F TERUMO SHEATH, UP AND OVER THE AORTIC ARCH. THE CATHETER WAS PREPPED IN THE STRAIGHT CONFIGURATION. THE CATHETER TIP FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE LOCKED IN THE PROXIMAL POSITION AND DURING PREP THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THERE WAS NO DIFFICULTY RETRACTING THE CANNULA BACK INTO THE CATHETER. THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP. AN ABBOTT SPARTICORE COMMAND ES GUIDEWIRE WAS USED IN THE PROCEDURE. THERE WAS DIFFICULTY ADVANCING OVER THE AORTIC ARCH AND THE DEVICE NEVER REACHED THE LESION WHICH WAS IN THE DISTAL SUPERFICIAL FEMORAL ARTERY TO THE LEFT POPLITEAL. THE LESION WAS HEAVILY CALCIFIED BUT THE VESSEL WAS NOT TORTUOUS. THE DEVICE WAS REMOVED AS A SINGLE UNIT. THERE WAS NO PATIENT INJURY. PRELIMINARY COMMENTS OF THE RETURNED DEVICE INDICATE THE DEVICE WAS RECEIVED WITH DISTAL TIP STRETCHED AT 2.5 CM. PHOTOGRAPHS WERE RECEIVED AND ARE BEING EVALUATED.