OUTBACK ELITE RE-ENTRY CATHETER

Additional Manufacturer Narrative

THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

DURING AN UNSPECIFIED INTERVENTIONAL PROCEDURE, AN OUTBACK ELITE120CM RE-ENTRY CATHETER WOULD NOT RETRACT DURING USE IN A PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED. THE CATHETER WAS PREPPED IN THE STRAIGHT CONFIGURATION AND THE CANNULA TIP FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE LOCKED IN THE PROXIMAL POSITION. THERE WAS NO DIFFICULTY RETRACTING THE CANNULA BACK INTO THE CATHETER DURING PREP. THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP. THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK OVER THE GUIDEWIRE OR TROUBLE LOADING A GUIDEWIRE WITH THE OUTBACK LTD. THE BRAND OF GUIDEWIRE USED WAS NOT PROVIDED. THERE WAS ALSO NO DIFFICULTY ADVANCING THE OUTBACK TO THE LESION. THE USER DID NOT ENCOUNTER RESISTANCE WHEN TORQUING THE DEVICE. THE "LT" DIRECTIONAL MARKER BAND SLOT WAS ORIENTED TOWARD THE DESIRED VASCULAR LOCATION (TARGET SITE) PRIOR TO ACTUATION OF THE HANDLE DEPLOYMENT SLIDE. ONCE AT THE LESION DID THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THE PHYSICIAN WAS NOT ABLE TO RE-ENTER THE VESSEL WITH THE GUIDEWIRE. THERE WAS NO RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT AND NO ABNORMAL FORCE WAS REQUIRED. HOWEVER, THE CANNULA WAS MOSTLY RETRACTED PRIOR TO CATHETER WITHDRAWAL. THERE WAS NO VESSEL DAMAGE DURING REMOVAL OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

Additional Manufacturer Narrative

A REPORT WAS RECEIVED THAT THE CANNULA OF A 120CM OUTBACK ELITE RE-ENTRY CATHETER COULD NOT BE RETRACTED DURING USE ON A PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT INJURY. THE EVENT INVOLVED A PATIENT UNDERGOING AN UNSPECIFIED PERCUTANEOUS INTERVENTION. THE PATIENT¿S VASCULATURE WAS ACCESSED AND AN UNKNOWN GUIDEWIRE ADVANCED TOWARDS THE TARGET LESION. THE SITE REPORTED THAT THE CATHETER HAD BEEN PREPPED IN A STRAIGHT CONFIGURATION. NO DIFFICULTY WAS EXPERIENCED WHEN RETRACTING AND DEPLOYING THE CANNULA AND THERE WAS ONE TO ONE RESPONSE OF THE NOSECONE WHILE ROTATING THE HEMOSTASIS VALVE DURING PREP. PRIOR TO LOADING THE CATHETER ONTO THE GUIDEWIRE, THE SITE REPORTED THAT THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION AND THE CANNULA WAS RETRACTED INTO THE CATHETER. NO DIFFICULTY WAS EXPERIENCED WHILE LOADING THE CATHETER ONTO THE GUIDEWIRE OR WHILE ADVANCING IT TOWARDS THE TARGET LESION. NO DIFFICULTY WAS ENCOUNTERED WHEN TORQUING THE DEVICE. THE SITE REPORTED THAT THE ¿LT¿ DIRECTIONAL MARKER WAS CORRECTED ORIENTED TOWARDS THE TARGET LESION PRIOR TO ACTUATING THE HANDLE DEPLOYMENT SLIDE AND THAT THE CANNULA ACTUATED SMOOTHLY. ONCE THE CANNULA WAS DEPLOYED, THEY WERE NOT ABLE TO ADVANCE THE GUIDEWIRE TO RE-ENTER THE TRUE LUMEN OF THE VESSEL. THE PHYSICIAN OPTED TO REMOVE THE DEVICE WAS NOT ABLE TO FULLY RETRACT THE CANNULA FOR THIS WITHDRAWAL. NO DIFFICULTY WAS EXPERIENCED WHILE REMOVING THE CATHETER AND NO ABNORMAL FORCE WAS REQUIRED DURING THE WITHDRAWAL. NO VESSEL INJURY OCCURRED DURING CATHETER REMOVAL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT OF PRODUCTS REVEALED THAT IT MET SPECIFICATION PRIOR TO RELEASE. 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 INSTRUCTIONS FOR USE (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. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO THE MANUFACTURING PROCESS. A RISK ASSESSMENT AND INVESTIGATION HAS BEEN INITIATED TO ADDRESS THIS ISSUE.