BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 10584326 · Received September 24, 2020

    Report

    Report Number
    3006425876-2020-00871
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 11, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE, ONE INTRODUCER NEEDLE, AND ONE ARS SYRINGE FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE GUIDE WIRE AND INTRODUCER NEEDLE. THE GUIDE WIRE WAS RETURNED INSERTED THROUGH THE INTRODUCER NEEDLE/ARS SUBASSEMBLY. VISUAL ANALYSIS REVEALED ONE KINK AND TWO CONTINUOUS BENDS ON THE GUIDE WIRE BODY. THIS RESULTED IN THE DISTAL J-BEND TO BE SLIGHTLY MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE KINK AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SPHERICAL AND SECURE TO THE ASSEMBLY. THE KINK IN THE GUIDE WIRE MEASURED 217MM FROM THE DISTAL WELD. THE GUIDE WIRE TOTAL LENGTH MEASURED 601MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 596MM-604MM PER THE GUIDE WIRE GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .802MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF .788MM-.826MM PER THE GUIDE WIRE GRAPHIC. THE NEEDLE CANNULA OUTER DIAMETER MEASURED .0498", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495MM-.0505MM PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER MEASURED .041" , WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE GUIDE WIRE WAS PASSED THROUGH THE RETURNED ARS/INTRODUCER NEEDLE SUBASSEMBLY. MINOR RESISTANCE WAS OBSERVED AT THE BENDS/KINK; HOWEVER, THE GUIDE WIRE WAS ABLE TO PASS COMPLETELY THROUGH THE SUBASSEMBLY. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE 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 EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE IFU ALSO STATES, "DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO REDUCE RISK OF POSSIBLE SEVERING OR DAMAGING OF GUIDEWIRE." THE REPORT OF A KINKED GUIDE WIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE CONTAINED ONE KINK AND TWO CONTINUOUS BENDS. THIS IN COMBINATION WITH THE DRIED BIOLOGICAL MATERIAL LIKELY CAUSED THE RESISTANCE. DESPITE THIS, THE INTRODUCER NEEDLE AND THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DURING INSERTION WHEN THE PHYSICIAN PULLED THE GUIDE WIRE, "THE NEEDLE AND THE GUIDE WIRE WERE NOT SEPARATED. THE GUIDE WIRE COULD NOT BE REMOVED FROM SYRINGE". IT WAS REPORTED THE SPRING WIRE GUIDE WAS STUCK IN THE NEEDLE. ANOTHER DEVICE WAS OBTAINED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM OR COMPLICATION REPORTED. THE PATIENT'S CO NDITION WAS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING INSERTION WHEN THE PHYSICIAN PULLED THE GUIDE WIRE, "THE NEEDLE AND THE GUIDE WIRE WERE NOT SEPARATED. THE GUIDE WIRE COULD NOT BE REMOVED FROM SYRINGE". IT WAS REPORTED THE SPRING WIRE GUIDE WAS STUCK IN THE NEEDLE. ANOTHER DEVICE WAS OBTAINED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM OR COMPLICATION REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042930 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F19G1236

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.| NONE REPORTED.