BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1892070 · Received November 8, 2010

    Report

    Report Number
    9616099-2010-00851
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 2, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE OUTBACK CATHETER WOULD NOT RETRACT DURING PREP. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE, THE DEVICE WAS PREPPED PER THE IFU AND ALL SPECIFIED PORTS WERE FLUSHED. THE CATHETER WAS COILED BEFORE PREP OF THE DEVICE. ONE NON STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. CANNULA WAS FULLY RETRACTED. NO ANOMALIES WERE DETECTED. PRESSURIZED WATER WAS APPLIED TO THE CATHETER THROUGH THE GUIDE WIRE PORT, AND EXIT THROUGH THE CANNULA PORT (AS EXPECTED), THAN THROUGH THE HEMOSTATIC ROTATING VALVE, AND EXIT THROUGH THE TIP (AS EXPECTED); NO ANOMALIES WERE DETECTED. A 0.014" GUIDE WIRE WAS INSERTED THROUGH THE TIP AND EXIT THROUGH THE GUIDE WIRE PORT (AS EXPECTED). THE GUIDE WIRE WAS THEN INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA RETRACTED, AND EXIT THROUGH THE TIP (AS EXPECTED). FINALLY, THE GUIDE WIRE WAS INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA DEPLOYED, AND EXIT THROUGH THE CANNULA (AS EXPECTED). IN NONE OF THE CASES RESISTANCE WAS NOTICED. CANNULA WAS FULLY DEPLOYED AND RETRACTED WITH NO ANOMALIES. CANNULA'S LENGTH WAS MEASURED ACCORDING TO (B)(4) REV. 16, AND IT WAS FOUND WITHIN SPECIFICATION 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 REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN. THE REPORTED MALFUNCTION BY THE CUSTOMER WAS NOT CONFIRMED THROUGH PRODUCT ANALYSIS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE NEEDLE OF THE OUTBACK CATHETER WOULD NOT RETRACT DURING PREP. THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE DEVICE WAS PREPPED PER IFU. ALL SPECIFIED PORTS WERE FLUSHED. THE CATHETER WAS COILED BEFORE PREP.

    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 15195618

    Patients

    Seq Age Sex Outcome Treatment
    1