BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-1/2"

    MDR report key: 12816818 · Received November 15, 2021

    Report

    Report Number
    9680794-2021-00607
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 29, 2021
    Report Date
    October 29, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE CATHETERIZATION DEVICE FOR ANALYSIS. VISUAL EXAMINATION REVEALED THE GUIDEWIRE WAS SEVERELY KINKED. THIS IS INDICATIVE OF DAMAGE THAT RESULTED FROM RESISTANCE WHEN THE END USER ATTEMPTED TO PASS IT THROUGH THE NEEDLE CANNULA. THE GUIDE WIRE WAS KINKED AT 86MM AND 95 MM FROM THE DISTAL TIP. THE TOTAL LENGTH OF THE GUIDE WIRE MEASURED TO BE 117 MM WHICH IS WITHIN SPECIFICATIONS OF 113-117 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED TO BE 0.439 MM WHICH IS WITHIN SPECIFICATIONS OF 0.432-0.457 MM PER PRODUCT DRAWING. FUNCTIONAL TESTING WAS PERFORMED PER IFU STATEMENT "STABILIZE POSITION OF INTRODUCER NEEDLE AND CAREFULLY ADVANCE SPRING-WIRE GUIDE INTO VESSEL USING SPRING-WIRE GUIDE HANDLE". DURING FUNCTIONAL TESTING , THE GUIDE WIRE WAS UNABLE TO ADVANCE AS EXPECTED. RESISTANCE WAS MET WHILE ATTEMPTING TO ADVANCE THE GUIDE WIRE THROUGH THE NEEDLE CANNULA. BASED ON THE FUNCTIONAL TESTING, THE CUSTOMER REPORTED ISSUE IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL. PRECAUTION: IF RESISTANCE IS ENCOUNTERED DURING GUIDEWIRE ADVANCEMENT DO NOT FORCE FEED, WITHDRAW ENTIRE UNIT AND ATTEMPT NEW PUNCTURE." THE REPORT OF GUIDE WIRE/NEEDLE RESISTANCE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE GUIDE WIRE WAS SEVERELY KINKED. FUNCTIONAL ANALYSIS CONFIRMED RESISTANCE WHILE ADVANCING THE GUIDE WIRE THROUGH THE NEEDLE CANNULA. DESPITE THE OBSERVED DEFECT, ALL RELEVANT DIMENSIONAL REQUIREMENTS WERE MET, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON A RECENT TREND FOR GUIDE WIRE/ NEEDLE RESISTANCE FOR DEVICES WITHIN RA-04220 KITS , A CAPA WAS INITIATED TO INVESTIGATE THIS ISSUE FURTHER. THE CAPA INVESTIGATION INDICATES THAT THE ISSUE IS MANUFACTURING RELATED. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS KINKED BEFORE USE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS KINKED BEFORE USE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707991 ARROW RA CATH SET: 20 GA X 1-1/2" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL INC. 14F19K0365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown