BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1862206 · Received October 8, 2010

    Report

    Report Number
    9616099-2010-00775
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ONE NON-STERILE OUTBACK CATHETER WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. CANNULA WAS DEPLOYED. THE CANNULA'S TIP WAS STICKING OUT OF THE CATHETER. ONCE THE CATHETER WAS COMPLETELY UNCOILED, THE CANNULA FULLY RETRACTED. NO KINKS OR BENTS WERE NOTICED. CANNULA'S LENGTH WAS MEASURED ACCORDING TO PRS039 REV 16, AND IT WAS FOUND WITHIN SPECIFICATION. PRESSURIZED WATER WAS APPLIED TO THE CATHETER THROUGH THE GUIDE WIRE PORT, AND EXITED THROUGH THE CANNULA PORT (AS EXPECTED), THAN THROUGH THE HEMOSTATIC ROTATING VALVE, AND EXITED THROUGH THE TIP (AS EXPECTED); NO ANOMALIES WERE DETECTED. A 0.014" GUIDE WIRE WAS INSERTED THROUGH THE TIP AND EXITED THROUGH THE GUIDE WIRE PORT (AS EXPECTED). THE GUIDE WIRE WAS THEN INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA RETRACTED, AND EXITED THROUGH THE TIP (AS EXPECTED). FINALLY, THE GUIDE WIRE WAS INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA DEPLOYED, AND EXITED THROUGH THE CANNULA (AS EXPECTED). IN NONE OF THE CASES RESISTANCE WAS NOTICED. CANNULA WAS FULLY DEPLOYED AND RETRACTED WITH NO ANOMALIES. 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 DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN. 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.

    Description of Event or Problem · 1

    DURING PREP, THE PHYSICIAN REMOVED THE PLASTIC COVER AND RETRACTED THE NEEDLE, BUT IT DID NOT RETRACT THE ENTIRE WAY. THERE WAS SOME DIFFICULTY EXPERIENCED DURING REMOVAL OF THE PLASTIC COVER. THERE WAS NO VISIBLE DAMAGE TO THE PRODUCT OR THE PACKAGING. ANOTHER ONE WAS OPENED AND THE PHYSICIAN PREPPED THE DEVICE THE SAME WAY. THIS TIME THE NEEDLE DID RETRACT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO 15167338

    Patients

    Seq Age Sex Outcome Treatment
    1