BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 20GA X 8CM

    MDR report key: 9181661 · Received October 11, 2019

    Report

    Report Number
    3006425876-2019-00783
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 19, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K093050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE ARTERIAL CATHETER, GUIDE WIRE AND INTRODUCER NEEDLE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CORE WIRE WAS BROKEN. BASED ON THE DIMENSIONAL INSPECTION, ONLY 305MM OF THE GUIDE WIRE WAS RETURNED. THIS MEANS AROUND 50MM OF THE WIRE WAS NOT RETURNED. THEREFORE, THE EXACT LOCATION OF THE CORE WIRE BREAKAGE IS UNKNOWN. THE PROXIMAL WELD APPEARED INTACT. MULTIPLE KINKS WERE ALSO OBSERVED THROUGHOUT THE GUIDE WIRE BODY. NO DEFECTS OR ANOMALIES WERE OBSERVED ON THE RETURNED CATHETER OTHER THAN DRIED BLOOD. KINKS IN THE GUIDE WIRE MEASURED 45MM, 89MM, 234MM AND 270M FROM THE DISTAL END. THE OVERALL LENGTH OF THE GUIDE WIRE BODY WAS 305MM WHICH WAS NOT WITHIN SPECIFICATION OF 345-355MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 518MM WHICH IS WITHIN SPECIFICATION OF .508-.533MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE CATHETER MEASURED .58MM WHICH IS WITH SPECIFICATION OF 0.58-0.61MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE NEEDLE CANNULA MEASURED .023" WHICH IS WITHIN SPECIFICATION OF .023-.033" PER PRODUCT DRAWING. THE RETURNED CATHETER WAS ATTEMPTED TO BE FLUSHED WITH WATER TO FUNCTIONALLY TEST THE CATHETER. HOWEVER, A SIGNIFICANT AMOUNT OF BIOLOGICAL MATERIAL WAS BLOCKING THE CATHETER BODY. ONCE THE DRIED BLOOD WAS REMOVED. THE CATHETER FUNCTIONED AS EXPECTED. THE UNDAMAGED PORTIONS OF THE RETURNED GUIDE WIRE PASSED THROUGH THE RETURNED CATHETER WITH MINIMAL RESISTANCE. THE UNDAMAGED PORTIONS OF THE RETURNED GUIDE WIRE PASSED THROUGH THE RETURNED INTRODUCER NEEDLE WITH MINIMAL RESISTANCE. A DHR REVIEW WAS COMPLETED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT WARNS THE USER "DO NOT WITHDRAW SPRING-WIRE GUIDE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OF SPRING-WIRE GUIDE." THE REPORTED COMPLAINT OF A SEPARATED GUIDE WIRE WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE CORE WIRE WAS RETURNED BROKEN, HOWEVER ONLY ONE PIECE WAS RETURNED. THE OVERALL LENGTH OF THE CORE WIRE RETURNED MEASURED 305MM, WHICH MEANS AROUND 50MM OF THE WIRE WAS NOT RETURNED. ALSO, SINCE ONLY PART OF THE WIRE WAS RETURNED, IT IS UNKNOWN EXACTLY WHERE THE CORE WIRE BROKE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE BREAKAGE. QUARTERLY TRENDING INDICATES A LOW, STABLE RATE FOR SEPARATED GUIDE WIRE COMPLAINTS. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: PATIENT WHO REQUIRES CHANNELING OF THE ARTERIAL LINE, CANNULA WITHOUT PROBLEM AND THE GUIDE ARE ADVANCED, WHEN THE CATHETER IS ADVANCED THROUGH THE GUIDE, AND AN ATTEMPT IS MADE TO REMOVE THE GUIDE, IT DOES NOT COME OUT, FEELS FORCED, SO IT IS NECESSARY TO REMOVE THE CATHETER MOUNTED ON THE GUIDE AGAIN SO THAT IT CAN BE REMOVED. 20 GA, 8CM, LOT THE GUIDE IS TWISTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: PATIENT WHO REQUIRES CHANNELING OF THE ARTERIAL LINE, CANNULA WITHOUT PROBLEM AND THE GUIDE ARE ADVANCED, WHEN THE CATHETER IS ADVANCED THROUGH THE GUIDE, AND AN ATTEMPT IS MADE TO REMOVE THE GUIDE, IT DOES NOT COME OUT, FEELS FORCED, SO IT IS NECESSARY TO REMOVE THE CATHETER MOUNTED ON THE GUIDE AGAIN SO THAT IT CAN BE REMOVED. 20 GA, 8CM, LOT THE GUIDE IS TWISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976773 ARROW ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F19C0464

    Patients

    Seq Age Sex Outcome Treatment
    1