OUTBACK ELITE RE-ENTRY CATHETER

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, OUTBACK WAS OPENED AND USED IN BODY WITH NO ISSUES. TECH WAS SHOWING STUDENT PRODUCT OUTSIDE OF BODY AND WHILE RETRACTING AND FIRING THE NEEDLE SEVERAL TIMES, THE NEEDLE STOPPED RETRACTING. THE PRODUCT WAS SENT IN FOR REVIEW. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE AND ALL SPECIFIED PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN WITH HEPARINIZED SALINE. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT AND IT ACTUATED SMOOTHLY. IT WAS RETRACTED FULLY WITH NO DIFFICULTY. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK AND THE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. A STABILIZER GUIDEWIRE WAS USED WITH THE OUTBACK. THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK OVER THE GUIDEWIRE OR TO THE LESION. PROPER ORIENTATION WAS CONFIRMED UNDER FLUOROSCOPY PRIOR TO ACTUATION OF THE NEEDLE. IT WAS FULLY RETRACTED PRIOR TO REMOVAL FROM THE PATIENT AND THERE WAS NO DIFFICULTY DURING REMOVAL. WHILE OUTSIDE THE PATIENT, THE OUTBACK WAS NOT FLUSHED AGAIN AND IT WAS NOT HELD IN A STRAIGHT CONFIGURATION WHEN DEPLOYING THE NEEDLE. THERE WERE NO DAMAGES NOTED TO THE NEEDLE AFTER PATIENT USE. IT WAS REPORTED THAT THE NEEDLE WAS OUT. IT WAS REPORTED THAT THE DEPLOYMENT OF THE NEEDLE MAY HAVE BEEN UNUSUAL RIGHT BEFORE THE NEEDLE COULD NOT BE RETRACTED. THE SLIDER WAS ABLE TO BE RETRACTED IN THE HANDLE.

Additional Manufacturer Narrative

COMPLAINT CONCLUSION: AS REPORTED, OUTBACK WAS OPENED AND USED IN THE BODY WITH NO ISSUES. THE TECHNICIAN WAS SHOWING A STUDENT THE PRODUCT OUTSIDE OF THE BODY AND WHILE RETRACTING AND FIRING THE NEEDLE SEVERAL TIMES, THE NEEDLE STOPPED RETRACTING. THE PRODUCT WAS SENT IN FOR REVIEW. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE AND ALL SPECIFIED PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN WITH HEPARINIZED SALINE. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT AND IT ACTUATED SMOOTHLY. IT WAS RETRACTED FULLY WITH NO DIFFICULTY. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK AND THE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. A STABILIZER GUIDEWIRE WAS USED WITH THE OUTBACK. THERE WAS NO DIFFICULTY ADVANCING THE OUTBACK OVER THE GUIDEWIRE OR TO THE LESION. PROPER ORIENTATION WAS CONFIRMED UNDER FLUOROSCOPY PRIOR TO ACTUATION OF THE NEEDLE. IT WAS FULLY RETRACTED PRIOR TO REMOVAL FROM THE PATIENT AND THERE WAS NO DIFFICULTY DURING REMOVAL. WHILE OUTSIDE THE PATIENT, THE OUTBACK WAS NOT FLUSHED AGAIN AND IT WAS NOT HELD IN A STRAIGHT CONFIGURATION WHEN DEPLOYING THE NEEDLE. THERE WERE NO DAMAGES NOTED TO THE NEEDLE AFTER PATIENT USE. IT WAS REPORTED THAT THE NEEDLE WAS OUT. IT WAS REPORTED THAT THE DEPLOYMENT OF THE NEEDLE MAY HAVE BEEN UNUSUAL RIGHT BEFORE THE NEEDLE COULD NOT BE RETRACTED. THE SLIDER WAS ABLE TO BE RETRACTED IN THE HANDLE. ONE NON STERILE OUTBACK ELITE 120CM RE-ENTRY WAS RECEIVED COILED INSIDE A PLASTIC BAG. A BEND CONDITION WAS OBSERVED ON THE BODY SHAFT OF THE UNIT APPROXIMATELY AT 3.5 CM FROM THE DISTAL TIP END. THE CANNULA WAS RECEIVED FULLY DEPLOYED. THE CATHETER MEASURED 120.8 CM OF USABLE LENGTH. NEEDLE CANNULA DEPLOYMENT MEASURED 7MM LENGTH. THE USABLE LENGTH OF THE CATHETER AND NEEDLE WERE FOUND WITHIN SPECIFICATION. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. PER FUNCTIONAL TEST, THE CANNULA WAS SUCCESSFULLY RETRACTED AND ADVANCED SEVERAL TIMES VIA DISTAL MOVEMENT OF THE DEPLOYMENT SLIDER IN SPITE OF BENT CONDITION OBSERVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE ¿CANNULA/NEEDLE (OUTBACK ONLY) - RETRACTION DIFFICULTY-UNABLE TO¿ REPORTED BY THE CUSTOMER WAS NOT CONFIRMED AS THE CANNULA WAS SUCCESSFULLY RETRACTED AND ADVANCED SEVERAL TIMES. HOWEVER, A BENT CONDITION WAS OBSERVED ON THE BODY SHAFT OF THE UNIT. THE EXACT CAUSE OF THE BENT CONDITION OBSERVED ON THE BODY SHAFT OF THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE TO PREVENT BENT DEFECTS ON THE UNITS. THE PRODUCT INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER THAT EXCESSIVE CALCIFICATION AT THE SITE OF RE-ENTRY MAY IMPAIR THE DEVICE¿S PERFORMANCE. IT INSTRUCTS THE USER TO RETRACT THE CANNULA TIP INTO THE DEVICE BY FULLY RETRACTING THE HANDLE DEPLOYMENT SLIDE UNTIL IT STOPS. THE USER IS THEN TO RELEASE THE HANDLE DEPLOYMENT SLIDE BUTTON TO LOCK THE DEPLOYMENT SLIDE IN THE RETRACTED POSITION. THE USER IS THEN INSTRUCTED 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. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.