BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    MDR report key: 10703814 · Received October 20, 2020

    Report

    Report Number
    3006425876-2020-00888
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 27, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE SPRING WIRE GUIDE (SWG) AND THE ADVANCER TUBING FOR EVALUATION. THE SWG WAS NOT RETURNED IN THE ADVANCER TUBING. VISUAL EXAMINATION OF THE GUIDE WIRE REVEALED MULTIPLE KINKS AND BENDS THROUGHOUT THE GUIDEWIRE BODY. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE GUIDE WIRE, WHICH CONTRADICTS THE CUSTOMER REPORTED TIME OF DISCOVERY. THE J-BEND WAS ALSO MIS-SHAPED. MICROSCOPIC EXAMINATION CONFIRMED BOTH WELDS WERE PRESENT AND SPHERICAL. THE MOST SEVERE KINKS IN THE GUIDE WIRE BODY WERE LOCATED AT 250, 370, 417, AND 443 MM FROM THE PROXIMAL END. THE TOTAL LENGTH OF THE GUIDE WIRE MEASURED TO BE 599 MM WHICH IS WITHIN SPECIFICATIONS OF 596MM - 604 MM PER SWG PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED TO BE 0.856MM, WHICH IS WITHIN SPECIFICATIONS OF 0.838MM - 0.877MM PER PRODUCT DRAWING. THE RETURNED GUIDE WIRE WAS ADVANCED THROUGH AN 18GA LAB INVENTORY NEEDLE & LAB INVENTORY ARS SYRINGE WITH MINIMAL RESISTANCE. RESISTANCE WAS ONLY ENCOUNTERED AT THE KINKED PORTIONS OF THE GUIDEWIRE. A MANUAL TUG TEST CONFIRMED THE DISTAL AND PROXIMAL WELDS WERE FULLY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE KIT INCLUDES THE FOLLOWING WARNINGS, CAUTIONS AND INSTRUCTIONS FOR THE USER: "DO NOT USE IF PACKAGE HAS BEEN PREVIOUSLY OPENED OR DAMAGED." "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." "IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE SPRING-WIRE GUIDE AFTER CATHETER PLACEMENT, THE SPRING-WIRE MAY BE KINKED ABOUT THE TIP OF THE CATHETER WITHIN THE VESSEL." "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" "DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDEWIRE OR CATHETERS. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, A CHEST X-RAY SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." "PRACTITIONERS MUST BE AWARE OF THE POTENTIAL FOR ENTRAPMENT OF GUIDE WIRE BY ANY IMPLANTED DEVICE IN THE CIRCULATORY SYSTEM (IE. VENA CAVA FILTERS, STENTS). REVIEW PATIENT'S HISTORY BEFORE CATHETERIZATION PROCEDURE TO ASSESS FOR POSSIBLE IMPLANTS. CARE SHOULD BE TAKEN REGARDING THE LENGTH OF SPRING-WIRE GUIDE INSERTED. IT IS RECOMMENDED THAT IF PATIENT HAS A CIRCULATORY SYSTEM IMPLANT, CATHETER PROCEDURE BE DONE UNDER DIRECT VISUALIZATION TO MINIMIZE THE RISK OF GUIDEWIRE ENTRAPMENT." THE CUSTOMER REPORT OF GUIDE WIRE DAMAGE WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE GUIDEWIRE WAS KINKED. THE SAMPLE PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL TESTING, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE GUIDE WIRE WAS NOT RETURNED WITHIN ITS ADVANCER TUBING. THE TUBING SHOWED NO KINKS OR STRESS MARKS. THE PORTION OF THE GUIDE WIRE THAT KINKED WOULD HAVE BEEN PROTECTED BY THE ADVANCER TUBING. THE CUSTOMER REPORTED THE DEFECT WAS FOUND PRIOR TO USE; HOWEVER, THE RETURNED GUIDE WIRE CONTAINED OBVIOUS SIGNS OF USE. THEREFORE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED DUE TO THE DISCREPANCY BETWEEN THE RETURNED SAMPLE AND THE REPORTED COMPLAINT BY THE CUSTOMER. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE SPRING WIRE GUIDE (SWG) WAS FOUND KINKED PRIOR TO PATIENT USE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SPRING WIRE GUIDE (SWG) WAS FOUND KINKED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171402 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F20A0525

    Patients

    Seq Age Sex Outcome Treatment
    1