BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI SET

    MDR report key: 12145462 · Received July 9, 2021

    Report

    Report Number
    3006425876-2021-00675
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 17, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE SPRING WIRE GUIDE (SWG) INSERTED THROUGH AN INTRODUCER NEEDLE. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS UNRAVELED FROM THE DISTAL END. MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL WELD HAD SEPARATED DIRECTLY ADJACENT TO THE CORE WIRE BUT WAS STILL ATTACHED TO THE COIL WIRE. THE PROXIMAL WELD WAS INTACT AND APPEARED SPHERICAL. THE RETURNED INTRODUCER NEEDLE SHOWS EVIDENCE OF USE BUT NO OBVIOUS DEFECTS OR ANOMALIES. THE GUIDE WIRE CORE WIRE LENGTH FROM THE PROXIMAL WELD TO THE DISTAL END MEASURED 456MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450MM-458MM PER THE GUIDE WIRE GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .852MM , WHICH IS WITHIN THE SPECIFICATION LIMITS OF .838MM-.877MM PER THE GUIDE WIRE GRAPHIC. THE CANNULA OUTER DIAMETER MEASURED .050" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .050"-.051" PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL END MEASURED .041" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE RETURNED NEEDLE WAS ATTACHED TO A LAB INVENTORY ARROW RAULERSON SYRINGE (ARS). A LAB INVENTORY GUIDE WIRE WITH A DIAMETER OF .035" WAS THEN INSERTED THROUGH THE SUBASSEMBLY. LITTLE TO NO RESISTANCE WAS OBSERVED AS THE GUIDE WIRE WAS ABLE TO PASS COMPLETELY THROUGH THE SAMPLE NEEDLE. PERFORMED PER IFU STATEMENT "RAISE YOUR THUMB AND PULL THE ARROW ADVANCER APPROXIMATELY 4 CM TO 8 CM AWAY FROM THE SYRINGE. LOWER THUMB ONTO THE ARROW ADVANCER AND WHILE MAINTAINING A FIRM GRIP ON THE SPRING-WIRE GUIDE, PUSH THE ASSEMBLY INTO THE SYRINGE BARREL TO FURTHER ADVANCE THE SPRING-WIRE GUIDE. CONTINUE UNTIL SPRING-WIRE GUIDE REACHES DESIRED DEPTH". A MANUAL TUG TEST CONFIRMED THE PROXIMAL WELD WAS FULLY 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 CUT SPRING-WIRE GUIDE TO ALTER LENGTH. DO NOT WITHDRAW SPRING-WIRE GUIDE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OR DAMAGING OF SPRING-WIRE GUIDE." 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 RESISTANCE WAS FOUND BETWEEN SWG (SPRING WIRE GUIDE) AND NEEDLE PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED RESISTANCE WAS FOUND BETWEEN SWG (SPRING WIRE GUIDE) AND NEEDLE PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040513 ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 71F20F1241

    Patients

    Seq Age Sex Outcome Treatment
    1