BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 22 GA X 1-3/8"

    MDR report key: 12261439 · Received August 2, 2021

    Report

    Report Number
    9680794-2021-00374
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 15, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE CATHETERIZATION DEVICE FOR ANALYSIS. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE BODY CONTAINED A KINK TOWARDS THE PROXIMAL END. THIS IS INDICATIVE OF DAMAGE THAT RESULTED FROM RESISTANCE WHEN THE END USER ATTEMPTED TO PASS IT THROUGH THE NEEDLE CANNULA. THE TOTAL LENGTH OF THE RETURNED GUIDE WIRE MEASURED TO BE 125 MM WHICH IS WITHIN SPECIFICATIONS OF 122-126 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED TO BE 0.395 MM WHICH IS WITHIN SPECIFICATIONS OF 0.381-0.404 MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE NEEDLE CANNULA (MEASURED FROM BOTH THE DISTAL AND PROXIMAL ENDS) MEASURED TO BE 0.017" WHICH IS WITHIN SPECIFICATIONS OF 0.0165-0.0180" PER PRODUCT DRAWING. NO DIMENSIONAL ISSUES WERE DETECTED. 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 WITH NO RELEVANT FINDINGS. 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. 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-04122 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PHYSICIAN FAILED THE WIRE TO ADVANCE THROUGH THE NEEDLE AFTER IT ASSEMBLED WITH CATHETER BODY. AND FOUND IT WAS KINKED AT 0.2CM FROM THE TIP OF THE WIRE." NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PHYSICIAN FAILED THE WIRE TO ADVANCE THROUGH THE NEEDLE AFTER IT ASSEMBLED WITH CATHETER BODY. AND FOUND IT WAS KINKED AT 0.2CM FROM THE TIP OF THE WIRE." NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157238 ARROW RA CATH SET: 22 GA X 1-3/8" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL INC. 14F19M0198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.