BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14465116 · Received May 21, 2022

    Report

    Report Number
    9680794-2022-00314
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 28, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE CATHETERIZATION DEVICE AND LIDSTOCK FOR ANALYSIS. VISUAL INSPECTION REVEALED A SMALL BEND IN THE GUIDE WIRE NEAR THE DISTAL END. THE GUIDE WIRE TUBING WAS SLIGHTLY DEFORMED, BUT IT IS ASSUMED THIS OCCURRED DURING TRANSIT TO THE MORRISVILLE SITE SINCE THE CUSTOMER DID NOT REPORT THIS DAMAGE. MICROSCOPIC EXAMINATION CONFIRMED THE DISTAL WELD OF THE GUIDE WIRE WAS ATTACHED AND FULLY SPHERICAL. IT ALSO REVEALED WHAT APPEARED TO BE ADHESIVE RESIDUE ON THE WIRE BODY. THE OFFSET COILS IN THE SWG BODY WERE LOCATED 2 MM FROM THE DISTAL TIP. THE TOTAL LENGTH OF THE SWG MEASURED 4.5625", WHICH IS WITHIN SPECIFICATIONS OF 4.4375-4.6875" PER SWG WITH HANDLE GRAPHIC. THE OUTER DIAMETER OF THE SWG MEASURED 0.384 MM, WHICH IS WITHIN SPECIFICATIONS OF 0.381-0.404 MM PER SWG GRAPHIC. THE INNER DIAMETER OF THE NEEDLE CANNULA MEASURED 0.017", WHICH IS WITHIN SPECIFICATIONS OF 0.0165-0.0180" PER CANNULA GRAPHIC. FUNCTIONAL TESTING WAS PERFORMED BASED ON THE INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT STATES, "STABILIZE POSITION OF INTRODUCER NEEDLE AND CAREFULLY ADVANCE SPRING-WIRE GUIDE INTO VESSEL USING ACTUATING LEVER." 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 TO SUGGEST A MANUFACTURING RELATED CAUSE. THE IFU PROVIDED WITH THIS KIT WARNS THE USER "TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL. 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 INSPECTION REVEALED THE GUIDE WIRE CONTAINED A SMALL BEND TOWARDS THE DISTAL END. 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 THE SPRING WIRE GUIDE WAS FOUND KINKED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552517 ARROW RA CATH SET: 22 GA X 1-3/8" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC 14F19H0476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown