OUTBACK

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. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, WHILE TRYING TO RE-ENTER THE TRUE LUMEN DISTAL TO AN OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 120CM OUTBACK ELITE RE-ENTRY CATHETER WHICH WAS ADVANCED OVER A 300CM STABILIZER EXTRA SUPPORT .014 STEERABLE GUIDEWIRE, THE USER ADVANCED AND RETRACTED THE CANNULA THREE TO FOUR TIMES WITHOUT ISSUE, BUT WITHOUT OBTAINING RE-ENTRY. THE OUTBACK WAS NOT ABLE TO FULLY ADVANCE THROUGH THE SUBINTIMAL SPACE AT THE LESION AND WAS UNABLE TO RE-ENTER THE TRUE LUMEN, WITH NO CALCIUM NOTED AT THE RE-ENTRY AREA. THE STABILIZER GUIDEWIRE WAS UNABLE TO ADVANCE OUT OF THE 22-GAUGE CANNULA ON THE SIDE OF THE CATHETER, AND THE OUTBACK RE-ENTRY CATHETER WAS REMOVED FROM THE PATIENT FOR INSPECTION. UPON REMOVAL AND INSPECTION, THE USER NOTICED THAT THE 22-GAUGE CANNULA WAS NO LONGER ATTACHED TO THE CATHETER. IT WAS NOTICED ON FLUOROSCOPY THAT THE DETACHED CANNULA WAS WEDGED IN THE SUBINTIMAL PLANE. ABNORMAL FORCE WAS REQUIRED DURING WITHDRAWAL, NECESSITATING A SECOND SET OF HANDS TO MAINTAIN WIRE POSITION WHILE THE DAMAGED OUTBACK WAS SLOWLY REMOVED. THE SEPARATED CANNULA DID NOT REMAIN ON THE WIRE AND WAS NOT REMOVED FROM THE PATIENT, REMAINING LODGED IN THE SUBINTIMAL PLANE AND DEEMED CLINICALLY INSIGNIFICANT BY THE PROCEDURALIST. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER OUTBACK DEVICE, WHICH PERFORMED TO SPECIFICATIONS AND SUCCESSFULLY ACHIEVED RE-ENTRY INTO THE TRUE LUMEN. THE STABILIZER GUIDEWIRE WAS NOT DAMAGED AND WAS REUSED SUCCESSFULLY WITH THE SECOND OUTBACK DEVICE. ACCESS THROUGH THE RIGHT FEMORAL ARTERY WAS USED FOR THIS PROCEDURE AS THERE WERE COMPLICATIONS WITH THE LEFT FEMORAL ARTERY WHICH WERE PRESENT AT THE START OF THE PROCEDURE. THE INTENDED LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET VESSEL WAS CALCIFIED BUT NOT TORTUOUS. THE SUBINTIMAL TRACT WAS PRE-DILATED 3MM PRIOR TO PASSAGE OF THE OUTBACK ELITE RE-ENTRY CATHETER. THE OUTBACK ELITE RE-ENTRY CATHETER WAS FLUSHED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO ABNORMALITIES OBSERVED. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT AND ACTUATED SMOOTHLY. NO RESISTANCE OR FRICTION WAS EXPERIENCED WHILE ADVANCING THE OUTBACK CATHETER OVER THE STABILIZER GUIDEWIRE WIRE, AND NO RESISTANCE WAS ENCOUNTERED WHEN TORQUING THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, G3, G6, H1, H2, H3, H6, AND H11. COMPLAINT CONCLUSION: AS REPORTED, WHILE TRYING TO RE-ENTER THE TRUE LUMEN DISTAL TO AN OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 120CM OUTBACK ELITE RE-ENTRY CATHETER WHICH WAS ADVANCED OVER A 300CM STABILIZER EXTRA SUPPORT .014 STEERABLE GUIDEWIRE, THE USER ADVANCED AND RETRACTED THE CANNULA THREE TO FOUR TIMES WITHOUT ISSUE, BUT WITHOUT OBTAINING RE-ENTRY. THE OUTBACK WAS NOT ABLE TO FULLY ADVANCE THROUGH THE SUBINTIMAL SPACE AT THE LESION AND WAS UNABLE TO RE-ENTER THE TRUE LUMEN, WITH NO CALCIUM NOTED AT THE RE-ENTRY AREA. THE STABILIZER GUIDEWIRE WAS UNABLE TO ADVANCE OUT OF THE 22-GAUGE CANNULA ON THE SIDE OF THE CATHETER, AND THE OUTBACK RE-ENTRY CATHETER WAS REMOVED FROM THE PATIENT FOR INSPECTION. UPON REMOVAL AND INSPECTION, THE USER NOTICED THAT THE 22-GAUGE CANNULA WAS NO LONGER ATTACHED TO THE CATHETER. IT WAS NOTICED ON FLUOROSCOPY THAT THE DETACHED CANNULA WAS WEDGED IN THE SUBINTIMAL PLANE. ABNORMAL FORCE WAS REQUIRED DURING WITHDRAWAL, NECESSITATING A SECOND SET OF HANDS TO MAINTAIN WIRE POSITION WHILE THE DAMAGED OUTBACK WAS SLOWLY REMOVED. THE SEPARATED CANNULA DID NOT REMAIN ON THE WIRE AND WAS NOT REMOVED FROM THE PATIENT, REMAINING LODGED IN THE SUBINTIMAL PLANE AND DEEMED CLINICALLY INSIGNIFICANT BY THE PROCEDURALIST. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER OUTBACK DEVICE, WHICH PERFORMED TO SPECIFICATIONS AND SUCCESSFULLY ACHIEVED RE-ENTRY INTO THE TRUE LUMEN. THE STABILIZER GUIDEWIRE WAS NOT DAMAGED AND WAS REUSED SUCCESSFULLY WITH THE SECOND OUTBACK DEVICE. ACCESS THROUGH THE RIGHT FEMORAL ARTERY WAS USED FOR THIS PROCEDURE AS THERE WERE COMPLICATIONS WITH THE LEFT FEMORAL ARTERY WHICH WERE PRESENT AT THE START OF THE PROCEDURE. THE INTENDED LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET VESSEL WAS CALCIFIED BUT NOT TORTUOUS. THE SUBINTIMAL TRACT WAS PRE-DILATED 3MM PRIOR TO PASSAGE OF THE OUTBACK ELITE RE-ENTRY CATHETER. THE OUTBACK ELITE RE-ENTRY CATHETER WAS FLUSHED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO ABNORMALITIES OBSERVED. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT AND ACTUATED SMOOTHLY. NO RESISTANCE OR FRICTION WAS EXPERIENCED WHILE ADVANCING THE OUTBACK CATHETER OVER THE STABILIZER GUIDEWIRE WIRE, AND NO RESISTANCE WAS ENCOUNTERED WHEN TORQUING THE DEVICE. A NON-STERILE OUTBACK ELITE 120 CM RE-ENTRY DEVICE WAS RECEIVED COILED INSIDE A CLEAR PLASTIC BAG. UPON UNPACKING AND VISUAL INSPECTION, THE CANNULA WAS OBSERVED TO BE FULLY RETRACTED WITH THE SLIDER HANDLE SET TO THE RETRACTION POSITION. NO DAMAGE, FRACTURES, OR KINKING WAS NOTED, AND NO OTHER ANOMALIES WERE OBSERVED. DIMENSIONAL VERIFICATION SHOWED THE CATHETER USABLE LENGTH MEASURED 121 CM (SPECIFICATION 120.5 ± 1 CM), WITHIN ACCEPTABLE LIMITS. FUNCTIONAL TESTING PER DEPARTMENTAL PROCEDURE SHOWED THAT THE SLIDE BUTTON COULD NOT DEPLOY THE CANNULA, WHICH REMAINED RETRACTED; THIS CONDITION TYPICALLY OCCURS WHEN THE CANNULA IS OVER-RETRACTED OR RETRACTED WITH EXCESSIVE FORCE. THE DISTAL TIP ROTATED NORMALLY DURING TORQUE TESTING. DISASSEMBLY AND INSPECTION OF THE ENTIRE CANNULA CONFIRMED NO EVIDENCE OF FRACTURE, SEPARATION, OR DEFORMATION, AND VISION SYSTEM INSPECTION VERIFIED THE CANNULA¿S INTEGRITY WITH NO OBSERVED ANOMALIES. THE REPORTED ¿CTO CATHETER SYSTEM ¿ FAILURE TO CROSS AND CANNULA/NEEDLE (OUTBACK ONLY) ¿ FRACTURED/SEPARATED¿ COULD NOT BE SUBSTANTIATED BECAUSE THESE FAILURES CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. BASED ON THE INFORMATION PROVIDED, PROCEDURAL FACTORS CANNOT BE EXCLUDED. ADDITIONALLY, THE REPORTED ¿CANNULA/NEEDLE (OUTBACK ONLY) ¿ FRACTURED/SEPARATED¿ WAS NOT SEEN DURING THE PRODUCT EVALUATION. THE ENTIRE CANNULA (NEEDLE INCLUDED) WAS SEEN DURING THE EVALUATION. HOWEVER, THE NEEDLE DID NOT DEPLOY WHILE ACTUATING THE SLIDER DURING FUNCTIONAL ANALYSIS. THIS CONDITION TYPICALLY OCCURS WHEN THE CANNULA IS OVER-RETRACTED OR RETRACTED WITH EXCESSIVE FORCE. CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT; THEREFORE, INTRA-PROCEDURAL HANDLING CANNOT BE EXCLUDED. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION ABOUT SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿IF STRONG RESISTANCE IS FELT DURING CATHETER MANIPULATION/DELIVERY, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING FURTHER. CONSIDER USING A 3¿4 MM BALLOON AT LOW ATM TO DILATE POINTS OF RESISTANCE, AS NEEDED, ALONG DELIVERY TRACK. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW THE OUTBACK® ELITE RE-ENTRY CATHETER. EXCESSIVE ROTATION, BENDING OR KINKING OF THE OUTBACK® ELITE RE-ENTRY CATHETER MAY AFFECT ITS PERFORMANCE. WITHDRAW THE OUTBACK® ELITE RE ENTRY CATHETER IF IT BECOMES EXCESSIVELY KINKED.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.