BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 16 CM

    MDR report key: 11088449 · Received December 29, 2020

    Report

    Report Number
    3006425876-2020-01087
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE SPRING WIRE GUIDE (SWG), INTRODUCER NEEDLE AND LIDSTOCK FOR EVALUATION. VISUAL EXAMINATION REVEALED THE GUIDE WIRE WAS UNRAVELED AND WAS SLIGHTLY BENT THROUGHOUT ITS BODY. THE CORE WIRE SEPARATED FROM THE DISTAL WELD, BUT THE COILS WERE STILL ATTACHED. THE PROXIMAL WELD WAS INTACT AND APPEARED FULL AND SPHERICAL. THE RETURNED INTRODUCER NEEDLE SHOWS EVIDENCE OF USE BUT NO OBVIOUS DEFECTS OR ANOMALIES. THE MOST SEVERE BEND MEASURED 190 MM FROM THE DISTAL END. THE TOTAL LENGTH OF THE CORE WIRE MEASURED TO BE 454 MM WHICH IS WITHIN SPECIFICATIONS OF 450-458 MM PER PRODUCT DRAWING. THE GUIDE WIRE CONTAINED ONE SLIGHT BEND 193 MM FROM THE PROXIMAL END. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED TO BE 0.796 MM WHICH IS WITHIN SPECIFICATIONS OF 0.788-0.826 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE NEEDLE WAS MEASURED TO BE 0.050 INCHES WHICH IS WITHIN SPECIFICATIONS OF 0.050-0.051 INCHES PER PRODUCT DRAWING. THE INNER DIAMETER OF THE NEEDLE WAS MEASURED TO BE 0.041 INCHES WHICH IS WITHIN SPECIFICATIONS OF 0.041 - 0.043 INCHES PER PRODUCT DRAWING. THE GUIDEWIRE WAS INSERTED THROUGH THE NEEDLE WITH MINIMAL RESISTANCE. RESISTANCE WAS ONLY ENCOUNTERED AT THE DAMAGED PORTIONS OF THE GUIDEWIRE. A MANUAL TUG TEST CONFIRMED THE PROXIMAL WELD WAS FULLY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THE IFU PROVIDED WITH THIS KIT INCLUDES THE FOLLOWING WARNINGS, CAUTIONS AND INSTRUCTIONS: "DO NOT CUT GUIDEWIRE TO ALTER LENGTH.". "DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OR DAMAGING OF GUIDEWIRE.". "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE.". "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.". "CLINICIANS MUST BE AWARE OF POTENTIAL ENTRAPMENT OF THE GUIDEWIRE BY ANY IMPLANTED DEVICE IN CIRCULATORY SYSTEM. IT IS RECOMMENDED THAT IF PATIENT HAS A CIRCULATORY SYSTEM IMPLANT, CATHETER PROCEDURE BE DONE UNDER DIRECT VISUALIZATION TO REDUCE RISK OF GUIDEWIRE ENTRAPMENT.". THE REPORT OF AN UNRAVELED GUIDE WIRE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. 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

    IT WAS REPORTED THAT: "DURING INSERTION, THE SWG GOT STUCK IN THE NEEDLE. IT WAS IMPOSSIBLE TO REMOVE THE SWG. THERE WERE 4-5 CM STILL IN THE RIGHT INTERNAL JUGULAR OF THE PATIENT. SO THE STAFF REMOVED THE NEEDLE AND THE SWG IN THE SAME TIME AND THE GUIDE WAS UNRAVELED. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE ISSUE WAS SOLVED WITH SUCCESS BY OPENING A NEW KIT TO USE THE NEW NEEDLE AND THE NEW SWG.". THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN (B)(4),

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING INSERTION, THE SWG GOT STUCK IN THE NEEDLE. IT WAS IMPOSSIBLE TO REMOVE THE SWG. THERE WERE 4-5 CM STILL IN THE RIGHT INTERNAL JUGULAR OF THE PATIENT. SO THE STAFF REMOVED THE NEEDLE AND THE SWG IN THE SAME TIME AND THE GUIDE WAS UNRAVELED. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE ISSUE WAS SOLVED WITH SUCCESS BY OPENING A NEW KIT TO USE THE NEW NEEDLE AND THE NEW SWG." THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552710 ARROW CVC SET: 3-LUMEN 7 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. IPN055195 71F20E1037

    Patients

    Seq Age Sex Outcome Treatment
    1