BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 5-LUMEN 8.5FR X 16CM

    MDR report key: 11637873 · Received April 8, 2021

    Report

    Report Number
    3006425876-2021-00351
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE ASSEMBLY, AN INTRODUCER NEEDLE, AND A LIDSTOCK FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE INTRODUCER NEEDLE. THE GUIDE WIRE WAS RETURNED PARTIALLY INSERTED AND STUCK INSIDE THE INTRODUCER NEEDLE. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS UNRAVELED TOWARDS THE DISTAL END. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL WELD HAD SEPARATED DIRECTLY ADJACENT TO THE DISTAL WELD BUT WAS STILL ATTACHED TO THE CORE WIRE. THE GUIDE WIRE TOTAL LENGTH FROM THE PROXIMAL WELD TO THE POINT OF SEPARATION ON THE CORE WIRE MEASURED 602MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 596MM-604MM PER THE GUIDE WIRE GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .790MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF .788MM-.826MM PER THE GUIDE WIRE GRAPHIC. THE INTRODUCER NEEDLE LENGTH (PER MEASUREMENT A IN THE NEEDLE GRAPHIC) MEASURED 68.5MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 67.13MM-68.91MM. THE CANNULA INNER DIAMETER AS THE PROXIMAL AND DISTAL END MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE CANNULA OUTER DIAMETER MEASURED .050", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA GRAPHIC. THE GUIDE WIRE WAS DISLODGED FROM THE INTRODUCER NEEDLE WITH MINOR DIFFICULTY. CONGEALED BLOOD WAS OBSERVED WITHIN THE NEEDLE CANNULA. UPON CLEARING THE CANNULA OF ALL BIOMATERIAL, THE GUIDE WIRE WAS ADVANCED AGAIN WITH LITTLE TO NO DIFFICULTY. PER IFU STATEMENT, "RAISE THUMB AND PULL ARROW ADVANCER APPROXIMATELY 4 - 8 CM AWAY FROM ARROW RAULERSON SYRINGE OR INTRODUCER NEEDLE. LOWER THUMB ONTO ARROW ADVANCER AND WHILE MAINTAINING A FIRM GRIP ON GUIDEWIRE, PUSH ASSEMBLY INTO SYRINGE BARREL TO FURTHER ADVANCE GUIDEWIRE. CONTINUE UNTIL GUIDEWIRE REACHES DESIRED DEPTH". A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EA SILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE REPORT OF A GUIDE WIRE NEEDLE RESISTANCE-UNRAVELED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE CORE WIRE SEPARATED FROM THE DISTAL WELD, BUT THE COILS WERE STILL ATTACHED. THE GUIDE WIRE AND INTRODUCER NEEDLE MET ALL FUNCTIONAL/DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO 11070:2014 STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USER ERROR (UNDUE FORCE) CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "GUIDEWIRE GETS STUCK IN NEEDLE". NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "GUIDEWIRE GETS STUCK IN NEEDLE". NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535258 ARROW CVC SET: 5-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL INC. IPN030801 71F20J2335

    Patients

    Seq Age Sex Outcome Treatment
    1