OUTBACK

Additional Manufacturer Narrative

CORRECTED FINAL REPORT SUBMITTED TO CORRECT SECTION H6; COMPONENT CODE 3088 ADDED COMPLAINT CONCLUSION: AS REPORTED, THREE SEPARATE 120CM OUTBACK ELITE RE-ENTRY CATHETERS WERE USED. THE NEEDLE ON FIRST OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT RETRACT ONCE INSIDE THE PATIENT. VESSEL RE-ENTRY WAS SUCCESSFUL, BUT THE NEEDLE ONLY PARTIALLY RETRACTED. A VASCULAR SURGEON CAREFULLY REMOVED THE DEVICE UNDER FLUOROSCOPY. A SECOND OUTBACK ELITE RE-ENTRY CATHETER WAS THEN USED; HOWEVER, COULD NOT FEED A SEPARATE UNKNOWN GUIDEWIRE THROUGH THE CATHETER. DIFFICULTY OCCURRED PRIOR TO ENTERING THE PATIENT, AND THE DEVICE NEVER ENTERED THE BODY. A THIRD OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT BACK OUT OVER THE SAME UNKNOWN GUIDEWIRE. THE RESISTANCE DURING WITHDRAWAL WAS BETWEEN THE CATHETER AND GUIDEWIRE, NOT THE VESSEL. THE DEVICE AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN BALLOON AND UNKNOWN STENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT HEAVILY CALCIFIED, NOT TORTUOUS, AND PRESENTED A CHRONIC TOTAL OCCLUSION (CTO). REGARDING THE FIRST OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), HEPARINIZED SALINE WAS USED FOR FLUSHING, AND CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT WITH SMOOTH OPERATION. THE NEEDLE WAS CONFIRMED FULLY RETRACTED BEFORE INSERTION, AND NO RESISTANCE OR ABNORMAL FORCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THERE WAS NO DAMAGE TO THE WIRE OR DIFFICULTY WITH THE SLIDER. REGARDING THE SECOND OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, FLUSHED WITHOUT DIFFICULTY, AND USED WITH A NON-CORDIS GUIDEWIRE, WHICH WAS NOT DAMAGED. THE GUIDEWIRE WAS RESHAPED BY THE USER. THE CANNULA WAS CONFIRMED RETRACTED, THE HANDLE LOCKED PRIOR TO GUIDEWIRE LOADING, AND THE DEVICE WAS HELD STRAIGHT DURING LOADING. REGARDING THE THIRD OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, WITH SMOOTH CANNULA ACTUATION VERIFIED OUTSIDE THE PATIENT. THE SAME NON-CORDIS GUIDEWIRE USED WITH THE SECOND OUTBACK DEVICE WAS USED WITH THE THIRD OUTBACK DEVICE. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THE NEEDLE WAS SUCCESSFULLY DEPLOYED AND RETRACTED, AND VESSEL RE-ENTRY WAS SUCCESSFUL. THE DEVICES WILL BE RETURNED FOR EVALUATION. A NON-STERILE UNIT OF THE OUTBACK ELITE 120CM RE-ENTRY DEVICE WAS RECEIVED COILED INSIDE A CLEAR PLASTIC BAG. UPON UNPACKING AND PERFORMING VISUAL INSPECTION, A KINKED AND BENT CONDITION WAS OBSERVED APPROXIMATELY 16 CM FROM THE DISTAL TIP. THE CANNULA NEEDLE WAS FULLY DEPLOYED, AND THE HANDLE SLIDER WAS IN THE RETRACTED POSITION WITH NO OTHER ANOMALIES NOTED. FUNCTIONAL TESTING WAS PERFORMED TO ASSESS DEVICE PERFORMANCE. DURING TESTING, THE HANDLE SLIDER WAS ACTUATED IN AN ATTEMPT TO RETRACT THE NEEDLE CANNULA; HOWEVER, IT FAILED TO RETRACT. DESPITE MULTIPLE ACTUATIONS, THE CANNULA REMAINED DEPLOYED, INDICATING A CANNULA FRACTURE OR SEPARATION. THIS TYPE OF FRACTURE TYPICALLY PRODUCES A LOCALIZED BENDING DEFORMATION THAT FOLLOWS THE SLIDER MOTION WHILE PREVENTING FULL RETRACTION. THE DEVICE WAS DISASSEMBLED FOR INTERNAL INSPECTION, WHICH CONFIRMED THAT THE CANNULA WAS FRACTURED AND SEPARATED APPROXIMATELY 15 CM FROM THE DISTAL END NEAR THE MARKER BAND. THE OBSERVED KINK AND CANNULA SEPARATION COULD NOT BE CONCLUSIVELY ATTRIBUTED TO A SPECIFIC ROOT CAUSE BASED ON THE AVAILABLE EVIDENCE. THE FINDINGS DO NOT INDICATE ANY MANUFACTURING OR DESIGN DEFICIENCIES. THE REPORTED ¿CANNULA/NEEDLE (OUTBACK ONLY)- RETRACTION DIFFICULTY-UNABLE TO¿ WAS OBSERVED AND WAS CAUSED BY THE MALFUNCTION ¿CANNULA WIRE PORT/GUIDEWIRE LUMEN (OUTBACK ONLY)- SEPARATED¿ WHICH WAS FOUND DURING THE PRODUCT EVALUATION. THE CANNULA COULD NOT BE RETRACTED BECAUSE IT WAS SEPARATED INTO TWO PIECES, AND THE KINKED CONDITION SUGGESTS EXCESSIVE BENDING CONTRIBUTED TO THESE FINDINGS. NO DAMAGES WERE NOTED TO THE DEVICE PRIOR TO INSERTING THE DEVICE INSIDE THE PATIENT THEREFORE, PROCEDURAL AND HANDLING FACTORS 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 FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT OF MAKING 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 AND PRODUCT ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AS REPORTED, THREE SEPARATE 120CM OUTBACK ELITE RE-ENTRY CATHETERS WERE USED. THE NEEDLE ON FIRST OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT RETRACT ONCE INSIDE THE PATIENT. VESSEL RE-ENTRY WAS SUCCESSFUL, BUT THE NEEDLE ONLY PARTIALLY RETRACTED. A VASCULAR SURGEON CAREFULLY REMOVED THE DEVICE UNDER FLUOROSCOPY. A SECOND OUTBACK ELITE RE-ENTRY CATHETER WAS THEN USED; HOWEVER, COULD NOT FEED A SEPARATE UNKNOWN GUIDEWIRE THROUGH THE CATHETER. THE DIFFICULTY OCCURRED PRIOR TO ENTERING THE PATIENT, AND THE DEVICE NEVER ENTERED THE BODY. A THIRD OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT BACK OUT OVER THE SAME UNKNOWN GUIDEWIRE. THE RESISTANCE DURING WITHDRAWAL WAS BETWEEN THE CATHETER AND GUIDEWIRE, NOT THE VESSEL. THE DEVICE AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN BALLOON AND UNKNOWN STENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT HEAVILY CALCIFIED, NOT TORTUOUS, AND PRESENTED A CHRONIC TOTAL OCCLUSION (CTO). REGARDING THE FIRST OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), HEPARINIZED SALINE WAS USED FOR FLUSHING, AND CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT WITH SMOOTH OPERATION. THE NEEDLE WAS CONFIRMED FULLY RETRACTED BEFORE INSERTION, AND NO RESISTANCE OR ABNORMAL FORCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THERE WAS NO DAMAGE TO THE WIRE OR DIFFICULTY WITH THE SLIDER. REGARDING THE SECOND OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, FLUSHED WITHOUT DIFFICULTY, AND USED WITH A NON-CORDIS GUIDEWIRE, WHICH WAS NOT DAMAGED. THE GUIDEWIRE WAS RESHAPED BY THE USER. THE CANNULA WAS CONFIRMED RETRACTED, THE HANDLE LOCKED PRIOR TO GUIDEWIRE LOADING, AND THE DEVICE WAS HELD STRAIGHT DURING LOADING. REGARDING THE THIRD OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, WITH SMOOTH CANNULA ACTUATION VERIFIED OUTSIDE THE PATIENT. THE SAME NON-CORDIS GUIDEWIRE USED WITH THE SECOND OUTBACK DEVICE WAS USED WITH THE THIRD OUTBACK DEVICE. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THE NEEDLE WAS SUCCESSFULLY DEPLOYED AND RETRACTED, AND VESSEL RE-ENTRY WAS SUCCESSFUL. THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION OF THE FIRST OUTBACK ELITE RE-ENTRY CATHETER REVEALED THAT THE CANNULA IS SEPARATED.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, B5, G3, G6, H1, H2, H3, H6, AND H11. COMPLAINT CONCLUSION: AS REPORTED, THREE SEPARATE 120CM OUTBACK ELITE RE-ENTRY CATHETERS WERE USED. THE NEEDLE ON FIRST OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT RETRACT ONCE INSIDE THE PATIENT. VESSEL RE-ENTRY WAS SUCCESSFUL, BUT THE NEEDLE ONLY PARTIALLY RETRACTED. A VASCULAR SURGEON CAREFULLY REMOVED THE DEVICE UNDER FLUOROSCOPY. A SECOND OUTBACK ELITE RE-ENTRY CATHETER WAS THEN USED; HOWEVER, COULD NOT FEED A SEPARATE UNKNOWN GUIDEWIRE THROUGH THE CATHETER. DIFFICULTY OCCURRED PRIOR TO ENTERING THE PATIENT, AND THE DEVICE NEVER ENTERED THE BODY. A THIRD OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT BACK OUT OVER THE SAME UNKNOWN GUIDEWIRE. THE RESISTANCE DURING WITHDRAWAL WAS BETWEEN THE CATHETER AND GUIDEWIRE, NOT THE VESSEL. THE DEVICE AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN BALLOON AND UNKNOWN STENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT HEAVILY CALCIFIED, NOT TORTUOUS, AND PRESENTED A CHRONIC TOTAL OCCLUSION (CTO). REGARDING THE FIRST OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), HEPARINIZED SALINE WAS USED FOR FLUSHING, AND CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT WITH SMOOTH OPERATION. THE NEEDLE WAS CONFIRMED FULLY RETRACTED BEFORE INSERTION, AND NO RESISTANCE OR ABNORMAL FORCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THERE WAS NO DAMAGE TO THE WIRE OR DIFFICULTY WITH THE SLIDER. REGARDING THE SECOND OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, FLUSHED WITHOUT DIFFICULTY, AND USED WITH A NON-CORDIS GUIDEWIRE, WHICH WAS NOT DAMAGED. THE GUIDEWIRE WAS RESHAPED BY THE USER. THE CANNULA WAS CONFIRMED RETRACTED, THE HANDLE LOCKED PRIOR TO GUIDEWIRE LOADING, AND THE DEVICE WAS HELD STRAIGHT DURING LOADING. REGARDING THE THIRD OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, WITH SMOOTH CANNULA ACTUATION VERIFIED OUTSIDE THE PATIENT. THE SAME NON-CORDIS GUIDEWIRE USED WITH THE SECOND OUTBACK DEVICE WAS USED WITH THE THIRD OUTBACK DEVICE. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THE NEEDLE WAS SUCCESSFULLY DEPLOYED AND RETRACTED, AND VESSEL RE-ENTRY WAS SUCCESSFUL. THE DEVICES WILL BE RETURNED FOR EVALUATION. A NON-STERILE UNIT OF THE OUTBACK ELITE 120CM RE-ENTRY DEVICE WAS RECEIVED COILED INSIDE A CLEAR PLASTIC BAG. UPON UNPACKING AND PERFORMING VISUAL INSPECTION, A KINKED AND BENT CONDITION WAS OBSERVED APPROXIMATELY 16 CM FROM THE DISTAL TIP. THE CANNULA NEEDLE WAS FULLY DEPLOYED, AND THE HANDLE SLIDER WAS IN THE RETRACTED POSITION WITH NO OTHER ANOMALIES NOTED. FUNCTIONAL TESTING WAS PERFORMED TO ASSESS DEVICE PERFORMANCE. DURING TESTING, THE HANDLE SLIDER WAS ACTUATED IN AN ATTEMPT TO RETRACT THE NEEDLE CANNULA; HOWEVER, IT FAILED TO RETRACT. DESPITE MULTIPLE ACTUATIONS, THE CANNULA REMAINED DEPLOYED, INDICATING A CANNULA FRACTURE OR SEPARATION. THIS TYPE OF FRACTURE TYPICALLY PRODUCES A LOCALIZED BENDING DEFORMATION THAT FOLLOWS THE SLIDER MOTION WHILE PREVENTING FULL RETRACTION. THE DEVICE WAS DISASSEMBLED FOR INTERNAL INSPECTION, WHICH CONFIRMED THAT THE CANNULA WAS FRACTURED AND SEPARATED APPROXIMATELY 15 CM FROM THE DISTAL END NEAR THE MARKER BAND. THE OBSERVED KINK AND CANNULA SEPARATION COULD NOT BE CONCLUSIVELY ATTRIBUTED TO A SPECIFIC ROOT CAUSE BASED ON THE AVAILABLE EVIDENCE. THE FINDINGS DO NOT INDICATE ANY MANUFACTURING OR DESIGN DEFICIENCIES. THE REPORTED ¿CANNULA/NEEDLE (OUTBACK ONLY)- RETRACTION DIFFICULTY-UNABLE TO¿ WAS OBSERVED AND WAS CAUSED BY THE MALFUNCTION ¿CANNULA WIRE PORT/GUIDEWIRE LUMEN (OUTBACK ONLY)- SEPARATED¿ WHICH WAS FOUND DURING THE PRODUCT EVALUATION. THE CANNULA COULD NOT BE RETRACTED BECAUSE IT WAS SEPARATED INTO TWO PIECES, AND THE KINKED CONDITION SUGGESTS EXCESSIVE BENDING CONTRIBUTED TO THESE FINDINGS. NO DAMAGES WERE NOTED TO THE DEVICE PRIOR TO INSERTING THE DEVICE INSIDE THE PATIENT THEREFORE, PROCEDURAL AND HANDLING FACTORS 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 FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT OF MAKING 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 AND PRODUCT ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

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, THREE SEPARATE 120CM OUTBACK ELITE RE-ENTRY CATHETERS WERE USED. THE NEEDLE ON FIRST OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT RETRACT ONCE INSIDE THE PATIENT. VESSEL RE-ENTRY WAS SUCCESSFUL, BUT THE NEEDLE ONLY PARTIALLY RETRACTED. A VASCULAR SURGEON CAREFULLY REMOVED THE DEVICE UNDER FLUOROSCOPY. A SECOND OUTBACK ELITE RE-ENTRY CATHETER WAS THEN USED; HOWEVER, COULD NOT FEED A SEPARATE UNKNOWN GUIDEWIRE THROUGH THE CATHETER. THE DIFFICULTY OCCURRED PRIOR TO ENTERING THE PATIENT, AND THE DEVICE NEVER ENTERED THE BODY. A THIRD OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT BACK OUT OVER THE SAME UNKNOWN GUIDEWIRE. THE RESISTANCE DURING WITHDRAWAL WAS BETWEEN THE CATHETER AND GUIDEWIRE, NOT THE VESSEL. THE DEVICE AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN BALLOON AND UNKNOWN STENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT HEAVILY CALCIFIED, NOT TORTUOUS, AND PRESENTED A CHRONIC TOTAL OCCLUSION (CTO). REGARDING THE FIRST OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), HEPARINIZED SALINE WAS USED FOR FLUSHING, AND CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT WITH SMOOTH OPERATION. THE NEEDLE WAS CONFIRMED FULLY RETRACTED BEFORE INSERTION, AND NO RESISTANCE OR ABNORMAL FORCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THERE WAS NO DAMAGE TO THE WIRE OR DIFFICULTY WITH THE SLIDER. REGARDING THE SECOND OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, FLUSHED WITHOUT DIFFICULTY, AND USED WITH A NON-CORDIS GUIDEWIRE, WHICH WAS NOT DAMAGED. THE GUIDEWIRE WAS RESHAPED BY THE USER. THE CANNULA WAS CONFIRMED RETRACTED, THE HANDLE LOCKED PRIOR TO GUIDEWIRE LOADING, AND THE DEVICE WAS HELD STRAIGHT DURING LOADING. REGARDING THE THIRD OUTBACK DEVICE, THE DEVICE WAS STORED AND PREPPED PER IFU, WITH SMOOTH CANNULA ACTUATION VERIFIED OUTSIDE THE PATIENT. THE SAME NON-CORDIS GUIDEWIRE USED WITH THE SECOND OUTBACK DEVICE WAS USED WITH THE THIRD OUTBACK DEVICE. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OR TRACKING. THE NEEDLE WAS SUCCESSFULLY DEPLOYED AND RETRACTED, AND VESSEL RE-ENTRY WAS SUCCESSFUL. THE DEVICES WILL BE RETURNED FOR EVALUATION.