BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW RA CATH SET: 20 GA X 1-3/4"

    MDR report key: 14377613 · Received May 12, 2022

    Report

    Report Number
    9680794-2022-00290
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 19, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED THREE IMAGES FOR ANALYSIS. ONE IMAGE SHOWED AN X-RAY OF WHAT APPEARS TO BE THE UNRAVELED GUIDE WIRE INSIDE THE PATIENT. THE SECOND AND THIRD IMAGES SHOW THE GUIDE WIRE INSERTED THROUGH THE CANNULA FROM THE CATHETERIZATION DEVICE. THE GUIDE WIRE APPEARS TO BE UNRAVELED/SEPARATED. SIGNS OF USE WERE ALSO OBSERVED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "IF RESISTANCE IS ENCOUNTERED WHILE ADVANCING SPRING-WIRE GUIDE DO NOT FORCE FEED. WARNING: DO NOT RETRACT SPRING-WIRE GUIDE AGAINST EDGE OF NEEDLE WHILE IN VESSEL TO MINIMIZE THE RISK OF SPRING-WIRE GUIDE DAMAGE". THE REPORT OF A SEPARATED GUIDE WIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS OF THE CUSTOMER SUPPLIED PHOTOS REVEALED THAT THE GUIDE WIRE WAS ADVANCED THROUGH THE NEEDLE CANNULA AND WAS UNRAVELED/SEPARATED. THE PROBABLE CAUSE OF THE RESISTANCE ENCOUNTERED BY THE CUSTOMER COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL COMPLAINT SAMPLE RETURNED FOR ANALYSIS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: AN ULTRASOUND-GUIDED RADIAL ARTERIAL LINE WAS BEING PLACED DURING AN EMERGENT SITUATION. THE PATIENT WAS IN CRITICAL CONDITION WITH DIFFICULT VASCULAR ACCESS. THE DOCTOR GAINED ACCESS TO THE ARTERY AND THEN FELT RESISTANCE AS HE ATTEMPTED TO REMOVE THE WIRE/NEEDLE ASSEMBLY. HE TROUBLESHOOTED THEN FELT A RELEASE OF THE WIRE AND WAS ABLE TO REMOVE IT. HE FOUND THE WIRE HAD UNRAVELED AND A PORTION HAD SHEARED OFF INTO THE PATIENT. THE PATIENT IS BEING OBSERVED AND THERE IS NO CURRENT PLAN TO REMOVE THE WIRE AT THIS TIME. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL, UNRELATED TO THE DEVICE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: AN ULTRASOUND-GUIDED RADIAL ARTERIAL LINE WAS BEING PLACED DURING AN EMERGENT SITUATION. THE PATIENT WAS IN CRITICAL CONDITION WITH DIFFICULT VASCULAR ACCESS. THE DOCTOR GAINED ACCESS TO THE ARTERY AND THEN FELT RESISTANCE AS HE ATTEMPTED TO REMOVE THE WIRE/NEEDLE ASSEMBLY. HE TROUBLESHOOTED THEN FELT A RELEASE OF THE WIRE AND WAS ABLE TO REMOVE IT. HE FOUND THE WIRE HAD UNRAVELED AND A PORTION HAD SHEARED OFF INTO THE PATIENT. THE PATIENT IS BEING OBSERVED AND THERE IS NO CURRENT PLAN TO REMOVE THE WIRE AT THIS TIME. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL, UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836324 ARROW RA CATH SET: 20 GA X 1-3/4" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other