BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 14880388 · Received June 30, 2022

    Report

    Report Number
    3006425876-2022-00601
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 18, 2022
    Report Date
    June 19, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A SINGLE GUIDE WIRE, MULTIPLE COMPONENTS FROM A CVC KIT, AND THE PRODUCT LIDSTOCK FOR EVALUATION. THE GUIDE WIRE WAS RETURNED WITHIN THE ADVANCER TUBE AND SHOWED EVIDENCE OF USE. THE GUIDE WIRE WAS OBSERVED TO HAVE A SEVERAL KINKS/BENDS THROUGHOUT ITS BODY. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDE WIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE KINKS IN THE GUIDE WIRE WERE LOCATED 211MM, 250MM, AND 360MM FROM THE DISTAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 600 MM WHICH IS WITHIN THE SPECIFICATION OF 596-604MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.790 MM WHICH IS WITHIN THE SPECIFICATION OF 0.788-0.826MM PER GUIDE WIRE PRODUCT DRAWING. THE RETURNED GUIDE WIRE WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT STATES, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE." THE GUIDE WIRE WAS ADVANCED THROUGH THE RETURNED ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDE WIRE. THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE GUIDE WIRE AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE WAS KINKED IN SEVERAL LOCATIONS THROUGHOUT ITS BODY. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE 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

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS KINKED DURING USE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS KINKED DURING USE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009062 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21H2254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown