BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 5670489 · Received May 20, 2016

    Report

    Report Number
    1036844-2016-00276
    Event Type
    Malfunction
    Date Received
    May 20, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 20, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE GUIDE WIRE KINKED DURING INSERTION WAS CONFIRMED. ONE GUIDE WIRE / ADVANCER ASSEMBLY WAS RE TURNED. THE CUSTOMER ALSO PROVIDED A PHOTOGRAPH SHOWING THE GUIDE WIRE ADVANCER INSIDE A PLASTIC BAG. THE GUIDE WIRE WAS NOT VISIBLE IN THE PHOTO. THE RETURNED GUIDE WIRE HAD THREE KINKS LOCATED 2, 3.5 & 12 CM FROM THE J-TIP WELD. MICROSCOPIC EXAMINATION CONFIRMED THAT BOTH WELDS APPEAR FULL AND SPHERICAL. A MANUAL TUG TEST CONFIRMED THAT BOTH WELDS REMAIN INTACT AND THE WIRE FEELS TYPICAL. THE GUIDE WIRE GRAPHIC SPECIFIES AN OUTSIDE DIAMETER OF .788/.826 MM AND A LENGTH OF 683 +/- 4 MM. THE GUIDE WIRE LENGTH WAS MEASURED AT 683 MM. THE OUTSIDE DIAMETER WAS MEASURED AT .806 MM USING MICROMETER GA-MM-0102-004. THE INSTRUCTION BOOKLET DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. SINCE THE GUIDE WIRE IS ALWAYS INSERTED THROUGH ANOTHER COMPONENT SUCH AS AN INTRODUCER NEEDLE, ARS SYRINGE OR INTRODUCER CATHETER AND NONE OF THESE COMPONENTS WERE RETURNED, THE PROBABLE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION IN THE MCIU, THE GUIDE WIRE KINKED. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323998 CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F14F0604

    Patients

    Seq Age Sex Outcome Treatment
    1