BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1830090 · Received September 10, 2010

    Report

    Report Number
    9616099-2010-00674
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, THE PHYSICIAN WAS MANIPULATING THE 'SPORT (NON-CORDIS) GUIDEWIRE. WHILE DOING THIS, THE GUIDEWIRE TIP UNRAVELED AND BECAME STUCK IN THE OUTBACK DEVICE AND WAS NOT ABLE TO BE FREED/WITHDRAWN. THE GUIDEWIRE DISTAL TIP SHEARED OFF AND WAS SUCCESSFULLY REMOVED TOGETHER WITH THE OUTBACK SYSTEM. THE PHYSICIAN USED ANOTHER OUTBACK TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE SEPARATED PIECE OF THE GUIDEWIRE WAS REMOVED FROM THE OUTBACK DEVICE AT THE PREP TABLE (AFTER REMOVAL OF THE WHOLE SYSTEM) USING FORCEPS. THE TARGET LESION FOR THE PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH FINAL ASSEMBLY LOT 15182885 AND THE ASSOCIATED CANNULA SUBASSEMBLY LOTS, BRAIDED CANNULA SUBASSEMBLY LOTS, OUTER SHAFT SUBASSEMBLY LOTS, AND NOSECONE SUBASSEMBLY LOTS REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON TEST RESULTS WHICH HAVE SHOWN COMPATIBILITY WITH THE OUTBACK, THE INSTRUCTIONS FOR USE LISTS GUIDE WIRES RECOMMENDED FOR USE WITH THE OUTBACK. IT FURTHER OUTLINES THAT FAILURE TO USE A RECOMMENDED GUIDE WIRE MAY RESULT IN DAMAGE TO THE GUIDE WIRE, SUCH AS, ABRASION OF THE HYDROPHILIC COATING, RELEASE OF POLYMER FRAGMENTS, SEPARATION OF THE WIRE, OR INABILITY TO WITHDRAW THE OB-LTD OVER THE GUIDE WIRE. THE SPORT WIRE USED FOR THIS PROCEDURE IS NOT INCLUDED IN THIS LIST. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENT; HOWEVER, THE USE OF A GUIDEWIRE OTHER THAN THOSE RECOMMENDED IN THE IFU MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS OF THE OUTBACK BASED ON THE DEVICE HISTORY RECORD REVIEW. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, THE PHYSICIAN WAS MANIPULATING THE SPORT (NON-CORDIS) GUIDEWIRE. WHILE DOING THIS, THE GUIDEWIRE TIP UNRAVELED AND BECAME STUCK IN THE OUTBACK DEVICE AND WAS NOT ABLE TO BE FREED/WITHDRAWN. THE GUIDEWIRE DISTAL TIP SHEARED OFF AND WAS SUCCESSFULLY REMOVED TOGETHER WITH THE OUTBACK SYSTEM. THE PHYSICIAN USED ANOTHER OUTBACK TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE SEPARATED PIECE OF THE GUIDEWIRE WAS REMOVED FROM THE OUTBACK DEVICE AT THE PREP TABLE (AFTER REMOVAL OF THE WHOLE SYSTEM) USING FORCEPS. THE TARGET LESION FOR THE PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15182885

    Patients

    Seq Age Sex Outcome Treatment
    1 SPORT GUIDEWIRE