BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 3212399 · Received July 9, 2013

    Report

    Report Number
    9616099-2013-00432
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AGREED TO THIS THERAPY AND ATK-AMPUTATION OF THE RIGHT LEG WAS PERFORMED. THE AMPUTATION WOUND IS PRIMARILY HEALING. 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. REVIEW OF LOT 15809297 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AN OUTBACK DEVICE WAS NOT ABLE TO PASS THE 45 DEGREE ANGLED AORTIC BIFURCATION AND THE DISTAL TIP SEPARATED AND EMBOLIZED INTO A PERIPHERAL VESSEL IN THE RIGHT LEG. TWO OTHER OUTBACK CATHETERS WERE USED TO TRY TO REACH THE TARGET LESION, BUT NEITHER DEVICE COULD CROSS OVER THE BIFURCATION. THE REPORTER INDICATED THAT SINCE THE INTERVENTIONAL RECANALIZATION OF THE SFA WAS NOT POSSIBLE, ABOVE THE KNEE AMPUTATION WAS ADVISED AS PREFERRED TREATMENT OPTION RATHER THAN A COMPLEX SURGICAL REVASCULARIZATION ATTEMPT (E.G. PIII BYPASS) FOR A NON-FUNCTIONAL LEG. THE PATIENT AGREED TO THIS THERAPY AND ABOVE THE KNEE (ATK) AMPUTATION OF THE RIGHT LEG WAS PERFORMED. THE AMPUTATION WOUND IS PRIMARILY HEALING. THE SEPARATED TIP WAS REMOVED TOGETHER WITH THE AMPUTATED LEG. THE PATIENT WAS ALREADY BEDBOUND FOR SOME YEARS DUE TO HEMIPARESIS DUE TO STROKE BEFORE THE INTERVENTION. THE INDICATION FOR THE INTERVENTION WAS CRITICAL ISCHEMIA RUTHERFORD V-VI OF THE PARETIC RIGHT LEG. THE PATIENT WAS IN A FRAGILE CONDITION WITH A WEIGHT OF (B)(6). A 7F TERUMO CROSSOVER SHEATH WAS USED. THE ACCESS SITE USED WAS THE LEFT FEMORAL. THE TARGET VESSEL WAS THE RIGHT SFA WITH 30 CM FIBROTIC CTO. THERE WAS NO DAMAGE TO THE OUTBACK DEVICE WHEN OPENING THE PACKAGE. ALL THE SPECIFIED PORTS OF THE DEVICE WERE PROPERLY FLUSHED. IT IS UNKNOWN IF THE PORTS AGAIN FLUSHED AFTER A 30 SECOND DELAY. THE CANNULA ACTION WAS VERIFIED DURING PREP. NO KINKS IN THE DEVICE WHERE APPARENT BEFORE LOADING. THE NEEDLE/CANNULA FULLY RETRACTED PRIOR TO INSERTION OF THE WIRE. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A 0.014 CHOICE PT II (BOSTON SCIENTIFIC) WAS USED. THERE WAS NO PROBLEM NOTED WITH THE GUIDEWIRE. TORQUING MANEUVERS WERE APPLIED TO OVERCOME THE RESISTANCE AND CROSS THE OUTBACK OVER THE BIFURCATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE TO THIS POINT. SUDDENLY THE TIP PART BEFORE THE SIDE-EXIT OF THE NEEDLE SEPARATED AND MIGRATED INTO THE PERIPHERAL VESSEL IN THE RIGHT LEG. THE DEVICE KINKED IN THE AREA OF SEPARATION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. (B)(4). ONE NON-STERILE CATHETER OUTBACK WAS RECEIVED COILED IN A PLASTIC BAG. DISTAL TIP WAS FOUND SEPARATED FROM THE REST OF THE CATHETER. NO OTHER DAMAGES WERE NOTED. DURING MICROSCOPIC ANALYSIS WELDING MARKS WERE NOTED IN THE DEVICE. 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 FAILURE CATHETER TIP/DISTAL TIP FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED WAS NOT DETERMINED; INNER LINER PRESENT MARKS OF WELDING. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS (DIFFICULTY TO ADVANCE OVER 45 DEGREE ANGLE ILIAC BIFURCATION, TORQUING ATTEMPTS) THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE THIS ISSUE. THE REPORTED CTO CATHETER SYSTEM/IMPEDE WAS NOT CONFIRMED IN THE OTHER TWO UNITS RETURNED FOR EVALUATION SINCE FUNCTIONAL TEST WAS SUCCESSFULLY PERFORMED. VESSEL CHARACTERISTICS ARE MOST LIKELY CONTRIBUTING FACTORS TO THE INABILITY TO ADVANCE THESE TWO UNITS OVER THE ILIAC BIFURCATION. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION UPDATED: AN OUTBACK DEVICE WAS NOT ABLE TO PASS THE 45 DEGREE ANGLED AORTIC BIFURCATION AND THE DISTAL TIP SEPARATED AND EMBOLIZED INTO A PERIPHERAL VESSEL IN THE RIGHT LEG. TWO OTHER OUTBACK CATHETERS WERE USED TO TRY TO REACH THE TARGET LESION, BUT NEITHER DEVICE COULD CROSS OVER THE BIFURCATION. THE REPORTER INDICATED THAT SINCE THE INTERVENTIONAL RECANALIZATION OF THE SFA WAS NOT POSSIBLE, ABOVE THE KNEE AMPUTATION WAS ADVISED AS PREFERRED TREATMENT OPTION RATHER THAN A COMPLEX SURGICAL REVASCULARIZATION ATTEMPT (E.G. PIII BYPASS) FOR A NON-FUNCTIONAL LEG. THE PATIENT AGREED TO THIS THERAPY AND ABOVE THE KNEE (ATK) AMPUTATION OF THE RIGHT LEG WAS PERFORMED. THE AMPUTATION WOUND IS PRIMARILY HEALING. THE SEPARATED TIP WAS REMOVED TOGETHER WITH THE AMPUTATED LEG. THE PATIENT WAS ALREADY BEDBOUND FOR SOME YEARS DUE TO HEMIPARESIS DUE TO STROKE BEFORE THE INTERVENTION. THE INDICATION FOR THE INTERVENTION WAS CRITICAL ISCHEMIA RUTHERFORD V-VI OF THE PARETIC RIGHT LEG. THE PATIENT WAS IN A FRAGILE CONDITION WITH A WEIGHT OF (B)(6). A 7F TERUMO CROSSOVER SHEATH WAS USED. THE ACCESS SITE USED WAS THE LEFT FEMORAL. THE TARGET VESSEL WAS THE RIGHT SFA WITH 30 CM FIBROTIC CTO. THERE WAS NO DAMAGE TO THE OUTBACK DEVICE WHEN OPENING THE PACKAGE. ALL THE SPECIFIED PORTS OF THE DEVICE WERE PROPERLY FLUSHED. IT IS UNKNOWN IF THE PORTS AGAIN FLUSHED AFTER A 30 SECOND DELAY. THE CANNULA ACTION WAS VERIFIED DURING PREP. NO KINKS IN THE DEVICE WHERE APPARENT BEFORE LOADING. THE NEEDLE/CANNULA FULLY RETRACTED PRIOR TO INSERTION OF THE WIRE. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A 0.014 CHOICE PT II (BOSTON SCIENTIFIC) WAS USED. THERE WAS NO PROBLEM NOTED WITH THE GUIDEWIRE. TORQUING MANEUVERS WERE APPLIED TO OVERCOME THE RESISTANCE AND CROSS THE OUTBACK OVER THE BIFURCATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE TO THIS POINT. SUDDENLY THE TIP PART BEFORE THE SIDE-EXIT OF THE NEEDLE SEPARATED AND MIGRATED INTO THE PERIPHERAL VESSEL IN THE RIGHT LEG. THE DEVICE KINKED IN THE AREA OF SEPARATION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. PROCEDURAL IMAGES WERE REQUESTED BUT WERE NOT AVAILABLE FOR REVIEW. 1-ICDTCA - ONE NON-STERILE CATHETER OUTBACK WAS RECEIVED COILED IN A PLASTIC BAG. DISTAL TIP WAS FOUND SEPARATED FROM THE REST OF THE CATHETER. NO OTHER DAMAGES WERE NOTED. DURING MICROSCOPIC ANALYSIS WELDING MARKS WERE NOTED IN THE DEVICE. 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 IFU CONTAINS THE FOLLOWING PRECAUTIONS: ALWAYS VISUALIZE TRACKING OF THE CATHETER TIP OVER THE AORTO-ILIAC BIFURCATION. IF STRONG RESISTANCE IS FELT DURING CATHETER MANIPULATION/DELIVERY, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING FURTHER. EXCESSIVE ROTATION, BENDING OR KINKING OF THE OB-LTD MAY AFFECT ITS PERFORMANCE. WITHDRAW THE OB-LTD IF IT BECOMES EXCESSIVELY KINKED. THE FAILURE CATHETER TIP/DISTAL TIP FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED WAS NOT DETERMINED AS THE INNER LINER PRESENT MARKS OF WELDING. THE REPORTED CTO CATHETER SYSTEM/IMPEDE WAS NOT CONFIRMED IN THE OTHER TWO UNITS RETURNED FOR EVALUATION SINCE FUNCTIONAL TEST WAS SUCCESSFULLY PERFORMED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE PATIENT¿S ANATOMY AND PROCEDURAL FACTORS (DIFFICULTY TO ADVANCE OVER 45 DEGREE ANGLE ILIAC BIFURCATION, RUTHERFORD V-VI, TORQUING ATTEMPTS) MAY HAVE CONTRIBUTED TO THE INABILITY TO ADVANCE THE UNITS OVER THE ILIAC BIFURCATION RESULTING IN THE SEPARATION OF THE DISTAL TIP IN ONE UNIT. NEITHER THE DHR REVIEW RESULTS NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURES EXPERIENCED COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, A RISK ASSESSMENT AND A THOROUGH INVESTIGATION WAS CONDUCTED WHICH DETERMINED THAT THERE IS NO MANUFACTURING RELATED CAUSE RELATED TO THIS TYPE OF FAILURE. NOTIFICATION TO CUSTOMERS OF POST MARKET SURVEILLANCE DATA FOR THIS FAILURE HAS BEEN INITIATED AS WELL AS RECOMMENDATION TO ADHERENCE TO PROCEDURAL STEPS AND OBSERVATION OF PRECAUTIONS OUTLINED IN THE PRODUCT¿S IFU. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, AN OUTBACK DEVICE WAS NOT ABLE TO PASS THE MOST PROXIMAL BEND OF THE 7F TERUMO X-OVER SHEATH IN A 45 DEGREE ANGLED AORTIC BIFURCATION, TORQUING MANEUVERS WERE APPLIED TO OVERCOME THE RESISTANCE AND TO ACHIEVE BRINGING THE DEVICE X-OVER. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE TO THIS POINT. SUDDENLY THE TIP PART BEFORE THE SIDE-EXIT OF THE NEEDLE SEPARATED AND MIGRATED INTO THE PERIPHERAL VESSEL IN THE RIGHT LEG. THE DEVICE KINKED IN THE AREA OF SEPARATION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. TWO OTHER OUTBACK CATHETERS WERE USED TO TRY TO REACH THE TARGET LESION (SFA DESCRIBED AS 30CM AND HAVING FIBROTIC CHRONIC TOTAL OCCLUSION).NO SUCCESS. THE OUTBACK CATHETERS COULD NOT CROSS THE BIFURCATION, TWICE. ABOVE THE KNEE RIGHT LEG WAS AMPUTATED. THE SEPARATED TIP WAS REMOVED TOGETHER WITH THE AMPUTATED LEG (TIP WAS WITHIN THE AMPUTATED PART OF THE LEG). THERE WAS NO DAMAGE TO THE OUTBACK DEVICE WHEN OPENING THE PACKAGE. ALL THE SPECIFIED PORTS OF THE DEVICE WERE PROPERLY FLUSHED. IT IS UNKNOWN IF THE PORTS AGAIN FLUSHED AFTER A 30 SECOND DELAY. THE CANNULA ACTION WAS VERIFIED DURING PREP. NO KINKS IN THE DEVICE WHERE APPARENT BEFORE LOADING. THE NEEDLE/CANNULA FULLY RETRACTED PRIOR TO INSERTION OF THE WIRE. THE CANNULA ACTUATE SMOOTHLY. APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A 0.014 CHOICE PT II (BOSTON SCIENTIFIC) WAS USED. THERE WAS NO PROBLEM NOTED WITH THE GUIDEWIRE. THE PATIENT WAS ALREADY BEDBOUND FOR SOME YEARS DUE TO HEMIPARESIS DUE TO STROKE BEFORE THE INTERVENTION. THE INTERVENTION WAS PERFORMED BECAUSE OF CRITICAL ISCHEMIA RUTHERFORD V-VI OF THE PARETIC RIGHT LEG. THE PATIENT WAS IN A FRAGILE CACHECTIC CONDITION WITH A WEIGHT OF (B)(6). SINCE THE INTERVENTIONAL RECANALIZATION OF THE SFA WAS NOT POSSIBLE WE RATHER ADVISED ABOVE THE KNEE AMPUTATION THAN A COMPLEX SURGICAL REVASCULARIZATION ATTEMPT (E.G. PIII BYPASS) FOR A NON-FUNCTIONAL LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312555 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15809297

    Patients

    Seq Age Sex Outcome Treatment
    1 7F TERUMO0.014 CHOICE PT II (BOSTON SCIENTIFIC)