BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PSI SET: 9 FR

    MDR report key: 9181129 · Received October 11, 2019

    Report

    Report Number
    9680794-2019-00383
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE, A DILATOR, AND A LIDSTOCK FOR ANALYSIS. NOT ONLY WAS THE GUIDE WIRE RETURNED INSERTED THROUGH THE DILATOR, BUT IT WAS ALSO RETURNED IN TWO SEPARATE PIECES. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS ALSO OBSERVED. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE COILS HAD SEPARATED. DESPITE THIS, THE DISTAL WELD WAS STILL PRESENT AND HAD SEPARATED FROM THE CORE WIRE. THIS CAUSED THE GUIDE WIRE TO UNRAVEL. THE DISTAL WELD WAS STILL ATTACHED TO THE COILS ON THE SEPARATED PORTION. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION ON THE CORE WIRE WAS SLIGHTLY TAPERED AND DISCOLORED INDICATING THAT THE CORE WIRE SEPARATED ADJACENT TO THE WELD POINT. THE PROXIMAL WELD APPEARED SECURE AND INTACT. VISUAL ANALYSIS ALSO REVEALED THAT THE DILATOR TIP WAS SLIGHTLY DAMAGED; HOWEVER, AS THE CUSTOMER MAKES NO REFERENCE TO THIS, IT IS ASSUMED THAT THE GUIDE WIRE CAUSED THIS DEFECT. THE GUIDE WIRE TOTAL LENGTH MEASURED 455MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450MM-458MM PER THE MARKED GUIDE WIRE GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .84MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF .838MM-.877MM PER THE MARKED GUIDE WIRE GRAPHIC. THE DILATOR LENGTH FROM THE HUB TO THE TIP MEASURED 7.047", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 6.437"-7.125" PER THE DILATOR GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .1175", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR INNER DIAMETER MEASURED .051", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.055" PER THE DILATOR EXTRUSION GRAPHIC. THE INNER DIAMETER OF THE DILATOR TIP MEASURED .037", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .036"-.038" PER THE DILATOR GRAPHIC. A LAB INVENTORY GUIDE WITH A DIAMETER OF .035" WAS PASSED THROUGH THE RETURNED DILATOR. LITTLE TO NO RESISTANCE WAS OBSERVED. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS FULLY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT CAUTIONS THE USER, "DO NOT WITHDRAW SPRING-WIRE GUIDE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OR DAMAGING OF SPRING-WIRE GUIDE". THE IFU ALSO WARNS, "ALTHOUGH THE INCIDENCE OF SPRING-WIRE GUIDE FAILURE IS EXTREMELY LOW, PRACTITIONER SHOULD BE AWARE OF THE POTENTIAL FOR BREAKAGE IF UNDUE FORCE IS APPLIED TO THE WIRE". THE REPORT OF A SEPARATED GUIDE WIRE WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE COILS HAD SEPARATED. THE GUIDE WIRE WAS ALSO UNRAVELED TOWARDS THE DISTAL END. THE DAMAGE WAS CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE GUIDE WIRE BODY. THE GUIDE WIRE AND THE DILATOR MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. 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 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 DOCTOR PLACED THE DILATOR OVER THE GUIDE WIRE AND INSERTED IT. WHEN HE PULLED THE GUIDE WIRE AND DILATOR OUT, HE REALIZED THAT THE GUIDE WIRE HAD BROKEN AND COME APART. PART OF THE COIL OF THE GUIDE WIRE WAS LEFT IN THE PATIENT, BUT SOME WAS STICKING OUT OF THE SKIN SO THEY WERE ABLE TO PULL IT OUT. THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED. NO PATIENT INJURY OR COMPLICATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR PLACED THE DILATOR OVER THE GUIDE WIRE AND INSERTED IT. WHEN HE PULLED THE GUIDE WIRE AND DILATOR OUT, HE REALIZED THAT THE GUIDE WIRE HAD BROKEN AND COME APART. PART OF THE COIL OF THE GUIDE WIRE WAS LEFT IN THE PATIENT, BUT SOME WAS STICKING OUT OF THE SKIN SO THEY WERE ABLE TO PULL IT OUT. THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED. NO PATIENT INJURY OR COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974170 ARROW PSI SET: 9 FR INTRODUCER, CATHETER DYB ARROW INTERNATIONAL INC. 14F19D0034

    Patients

    Seq Age Sex Outcome Treatment
    1