OUTBACK ELITE RE-ENTRY CATHETER

Additional Manufacturer Narrative

COMPLAINT CONCLUSION: A REPORT WAS RECEIVED THAT A 120CM OUTBACK ELITE RE-ENTRY CATHETER FAILED TO CROSS THE TARGET LESION. IN ADDITION, THE SITE REPORTED THAT THEY WERE UNABLE TO FULLY RETRACT THE CANNULA NEEDLE. THE OUTBACK CATHETER WAS REMOVED BY ADVANCING THE SHEATH OVER THE CATHETER PRIOR TO REMOVING IT WITH NO REPORTED PATIENT INJURY. THE EVENT INVOLVED A PATIENT UNDERGOING PERCUTANEOUS INTERVENTION OF A TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS DESCRIBED AS A CHRONIC TOTAL OCCLUSION, UN-CALCIFIED AND NON-TORTUOUS. THE SITE REPORTED THAT THE CATHETER HAD BEEN PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS DONE IN A STRAIGHT CONFIGURATION. THE PORTS HAD BEEN FLUSHED WITH HEPARINIZED SALINE FOLLOWED BY A 30 SECOND PAUSE AND THEN FLUSHED AGAIN. THE NEEDLE HAD DEPLOYED AND RETRACTED SMOOTHLY WITHOUT ISSUE DURING THIS PREP. NO DAMAGE WAS NOTED ON THE CATHETER OR ITS¿ NEEDLE PRIOR TO USE. THE PATIENT¿S VASCULATURE WAS ACCESSED AND A STABILIZER GUIDEWIRE ADVANCED TOWARDS THE LESION. NO DIFFICULTY OR RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE OUTBACK CATHETER OVER THE WIRE OR WHILE TORQUING THE DEVICE. FROM THE REPORT, IT THEN APPEARS THAT THE DEVICE WAS ADVANCED INTO THE SUBINTIMAL SPACE OF THE TARGET LESION BUT WAS THEN UNABLE TO CROSS INTO THE TRUE LUMEN BEYOND THE LESION. THE SITE REPORTED THAT THEY WERE THEN UNABLE TO FULLY RETRACT THE CANNULA NEEDLE. THE OUTBACK CATHETER WAS REMOVED BY ADVANCING THE SHEATH OVER THE CATHETER PRIOR TO REMOVING IT THEREBY ENDING THE PROCEDURE WITH NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE PRODUCT IFU CAUTIONS THE USERS THAT EXCESSIVE CALCIFICATION AT THE SITE OF RE-ENTRY MAY IMPAIR PERFORMANCE. THE IFU FURTHER INSTRUCTS USERS THAT IF RESISTANCE IS FELT DURING CANNULA DEPLOYMENT, THEY ARE TO NOT APPLY UNNECESSARY FORWARD PUSH ON THE DEVICE SINCE THIS MAY RESULT IN DAMAGE TO THE CANNULA TIP AND/OR SEPARATION OF THE CANNULA TIP. TO RETRACT THE CANNULA TIP, USERS ARE INSTRUCTED TO FULLY RETRACT THE HANDLE DEPLOYMENT SLIDE UNTIL IT STOPS. USERS ARE TO THEN RELEASE THE HANDLE DEPLOYMENT SLIDE BUTTON TO LOCK THE DEPLOYMENT SLIDE IN THE RETRACTED POSITION. THEY ARE TO ENSURE THAT THE CANNULA TIP IS FULLY RETRACTED INTO THE CATHETER LATERAL PORT, AND THE HANDLE DEPLOYMENT SLIDE IS LOCKED, PRIOR TO WITHDRAWING THE CATHETER OVER THE GUIDEWIRE. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT WAS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative

PLEASE NOTE THAT THE GENDER OF THE PATIENT IS UNKNOWN. THE DEVICE IS AVAILABLE TO BE RETURNED FOR ANALYSIS, BUT IT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, THE OUTBACK ELITE 120CM RE-ENTRY DEVICE FAILED TO CROSS THE CHRONIC TOTAL OCCLUSION IN THE SFA. THEN, THE NEEDLE COULD NOT BE FULLY RETRACTED INTO THE DEVICE WHILE IN THE PATIENT. THE NEEDLE WASN'T OUT TOO FAR, THEREFORE, THE SHEATH WAS ADVANCED OVER THE DEVICE AND IT WAS REMOVED. THE PROCEDURE ENDED AFTER THAT AS THE LESION COULD NOT BE CROSSED. DURING PREP OF THE OUTBACK, THE NEEDLE DEPLOYED AND RETRACTED SMOOTHLY WITHOUT ISSUE. THE TARGET VESSEL WAS NOT TORTUOUS OR CALCIFIED. THE DEVICE WAS PREPARED AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU) WITH NO APPARENT DAMAGE TO THE DEVICE NOTED PRIOR TO USE. THE PORTS WERE FLUSHED WITH HEPARINIZED SALINE, FOLLOWED BY A 30 SECOND PAUSE, THEN FLUSHED AGAIN. THE NEEDLE WAS NOT DAMAGED IN ANY WAY AND THE CATHETER WAS PREPPED IN A STRAIGHT CONFIGURATION. A STABILIZER GUIDEWIRE WAS USED WITH THE OUTBACK WITH NO DIFFICULTY ADVANCING THE CATHETER OVER THE WIRE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN TORQUING THE DEVICE. THE NEEDLE WAS NOT ABLE TO BE RETURNED INTO THE DEVICE ONCE IT WAS OUTSIDE OF THE PATIENT, AND IT WAS NOT DAMAGED IN ANY WAY AFTER REMOVAL.