BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 3800072 · Received May 8, 2014

    Report

    Report Number
    9616099-2014-00308
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICAL PRODUCTS: 7F PINNACLE SHEATH AND UNKNOWN .014 WIRE.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING USE OF AN OUTBACK CTO CATHETER, IT WAS REPORTED THAT THE DISTAL TIP SEPARATED DURING A DIFFICULT ATTEMPT TO ADVANCE OVER THE ILIAC BIFURCATION. THE SEPARATED TIP REMAINED ON THE WIRE, THEREFORE IT WAS JUST REMOVED WITH THE SHEATH. THERE WAS NO REPORTED HARM TO THE PATIENT. NO ADDITIONAL INTERVENTION WAS CONDUCTED. A 7F PINNACLE SHEATH AND .014 UNKNOWN WIRE WERE USED. THE REPORTER INDICATED THAT THE PHYSICIAN HAD TROUBLE ADVANCING THE OUTBACK OVER THE ILIAC BIFURCATION AND STATED THAT ¿ DURING LONG DIFFICULT ATTEMPT AT CROSSING OVER THE ILIAC BIFURCATION, WHICH NEVER HAPPENED, THE TIP SEPARATED BUT STAYED ON WIRE AND WAS REMOVED WITH SHEATH¿. THE SHEATH,WIRE, OUTBACK, AND SEPARATED TIP WERE RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS TO OBTAIN DETAILED PROCEDURAL AND VESSEL CHARACTERISTICS INFORMATION WERE UNSUCCESSFUL. ONE NON STERILE CATHETER OUTBACK WAS RECEIVED COILED INSIDE A PLASTIC BAG. BLOOD RESIDUES WERE NOTED IN THE CATHETER. THE TIP WAS BROKEN APPROXIMATED AT 1.0 CM FROM DISTAL TIP END AND SEPARATED. THE TIP WAS RIPPED SINCE OUTER LINER PRESENT ELONGATION. DISTAL TIP WAS RETURNED INSIDE A PLASTIC BAG. A KINK WAS OBSERVED AT 2.5CM FROM DISTAL TIP END. UNKNOWN CATHETER SHEATH INTRODUCER WAS RECEIVED WITH RETURNED DEVICE. THE UNIT IS NOT FUNCTIONAL USABLE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. PRESSURIZED WATER WAS APPLIED TO THE CATHETER THROUGH THE GUIDE WIRE PORT, AND EXIT THROUGH THE CANNULA PORT THEN THROUGH THE HAEMOSTATIC ROTATING VALVE, AND EXIT THROUGH THE TIP; NO ANOMALIES WERE DETECTED. THE RETURNED 0.014¿ GUIDE WIRE WAS INSERTED THROUGH THE TIP AND IT EXIT THROUGH THE GUIDE WIRE PORT. THE GUIDE WIRE WAS THEN INSERTED THROUGH THE GUIDE WIRE PORT, AND IT EXIT THROUGH THE TIP. CANNULA COULD BE FULLY DEPLOYED AND RETRACTED HOWEVER THE DEVICE WAS NOT FUNCTIONALLY USABLE SINCE THE NOSECONE WAS RIPPED AND A KINK WAS NOTED IN THE BODY SHAFT. THE CATHETER LENGTH WAS NOT POSSIBLE MEASURE SINCE THE NOSECONE WAS RIPPED AND THE CANNULA WAS DEPLOYED AND MEASURED 9.0MM OF LENGTH USABLE AND THE MEASURE WAS FOUND INSIDE SPECIFICATION. REVIEW OF LOT 15841081 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE IFU CONTAINS THE FOLLOWING PRECAUTIONS: 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. THE IFU INCLUDES TO ALWAYS VISUALIZE TRACKING OF THE CATHETER TIP OVER THE AORTO-ILIAC BIFURCATION IN THE PRECAUTIONS SECTION. TRACKING THE OUTBACK THROUGH AN ACUTE VESSEL ANGLE, SUCH AS THE AORTO-ILIAC BIFURCATION, MAY CONTRIBUTE TO THE EVENTS REPORTED. 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. THE FAILURE CTO CATHETER SYSTEM TRACKING DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED SINCE THE FUNCTIONALLY TEST COULD NOT BE PERFORMED DUE TO CONDITION OF THE RECEIVED DEVICE (THE NOSECONE WAS RIPPED AND THE BODY SHAFT WAS KINKED). THE EXACT CAUSE OF KINK IN THE BODY SHAFT COULD BE NOT DETERMINED. HOWEVER, CONTROLS ARE IN PLACE TO PREVENT DEFECTS SUCH AS KINKS IN THE SHAFT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE PATIENT¿S ANATOMY AND PROCEDURAL FACTORS (¿DIFFICULT ATTEMPTS TO CROSS OVER THE ILIAC BIFURCATION¿) ARE MOST LIKELY CONTRIBUTING FACTORS TO THE TRACKING DIFFICULTY REPORTED RESULTING IN KINK OF THE SHAFT AND SEPARATION OF THE DISTAL TIP. 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 SEPARATION OF THE DISTAL TIP. NOTIFICATION TO CUSTOMERS OF POST MARKET SURVEILLANCE DATA FOR THIS FAILURE HAS BEEN INITIATED AS WELL AS RECOMMENDATION TO ADHERE TO PROCEDURAL STEPS AND OBSERVATION OF PRECAUTIONS OUTLINED IN THE PRODUCT¿S IFU. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: ONE NON STERILE CATHETER OUTBACK WAS RECEIVED COILED INSIDE A PLASTIC BAG. BLOOD RESIDUES WERE NOTED IN THE CATHETER. THE TIP WAS BROKEN APPROXIMATED AT 1.0 CM FROM DISTAL TIP END AND SEPARATED. THE TIP WAS RIPPED SINCE OUTER LINER PRESENT ELONGATION. DISTAL TIP WAS RETURNED INSIDE A PLASTIC BAG. THE CATHETER LENGTH WAS NOT POSSIBLE MEASURE SINCE THE NOSECONE WAS RIPPED AND THE CANNULA WAS DEPLOYED AND MEASURED 9.0MM OF LENGTH USABLE. THE UNIT IS NOT FUNCTIONAL USABLE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. PRESSURIZED WATER WAS APPLIED TO THE CATHETER THROUGH THE GUIDE WIRE PORT, AND EXIT THROUGH THE CANNULA PORT THEN THROUGH THE HAEMOSTATIC ROTATING VALVE, AND EXIT THROUGH THE TIP; NO ANOMALIES WERE DETECTED. THE RETURNED 0.014¿ GUIDE WIRE WAS INSERTED THROUGH THE TIP AND IT EXIT THROUGH THE GUIDE WIRE PORT. THE GUIDE WIRE WAS THEN INSERTED THROUGH THE GUIDE WIRE PORT, AND IT EXIT THROUGH THE TIP. CANNULA COULD BE FULLY DEPLOYED AND RETRACTED. THE COMPLAINT WAS ADDRESSED ON A RISK ASSESSMENT. REVIEW OF LOT 15841081 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FAILURE CATHETER TIP/DISTAL TIP (OUTBACK ONLY) FRACTURED-SEPARATED/IN PATIENT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED COULD NOT BE DETERMINED; INNER LINER PRESENT MARKS OF WELDING. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THE COMPLAINT WAS INCLUDED IN AN INVESTIGATION RELATED TO THIS MATTER. 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 · 1

    DURING USE OF AN OUTBACK CTO CATHETER, IT WAS REPORTED THAT THE DISTAL TIP SEPARATED DURING A DIFFICULT ATTEMPT TO ADVANCE OVER THE ILIAC BIFURCATION. THE SEPARATED TIP REMAINED ON THE WIRE, THEREFORE IT WAS JUST REMOVED WITH THE SHEATH. NO HARM WAS DONE TO PATIENT AND PROCEDURE WAS THEN STOPPED. NO ADDITIONAL INTERVENTION WAS DONE. VASCULAR LAB TECH ALERTED THAT PHYSICIAN WAS USING THE OUTBACK CATHETER AND THE TIP SEPARATED FROM THE CATHETER. STATED THAT THE PHYSICIAN WAS USING A 7F PINNACLE SHEATH AND .014 WIRE. HE HAD TROUBLE ADVANCING THE OUTBACK OVER THE ILIAC BIFURCATION. DURING LONG DIFFICULT ATTEMPT AT CROSSING OVER THE ILIAC BIFURCATION, WHICH NEVER HAPPENED, THE TIP SEPARATED BUT STAYED ON WIRE AND WAS REMOVED WITH SHEATH. NO HARM WAS DONE TO PATIENT AND PROCEDURE WAS THEN STOPPED. NO ADDITIONAL INTERVENTION WAS DONE. THE SHEATH, WIRE, OUTBACK, AND SEPARATED TIP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278741 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15841081

    Patients

    Seq Age Sex Outcome Treatment
    1