BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL

    MDR report key: 12537306 · Received September 27, 2021

    Report

    Report Number
    9680794-2021-00473
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 3, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K011761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE DILATOR FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE DILATOR BODY. VISUAL ANALYSIS REVEALED THAT THE DISTAL TIP WAS SLIGHTLY FRAYED SPLIT. THE SHAPE OF THE OPENING WAS SLIGHTLY OVAL, WHICH INDICATES THAT UNDUE FORCE DURING INSERTION LIKELY CAUSED OR CONTRIBUTED TO THE DAMAGE. THE DILATOR BODY LENGTH FROM THE HUB TO THE DISTAL TIP MEASURED 7 1/16" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 6 1/2"-7 1/8" PER THE DILATOR GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .119" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR INNER DIAMETER AT THE PROXIMAL END MEASURED .051" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.055" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .036" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .036"-.038" PER THE DILATOR EXTRUSION GRAPHIC. THE RETURNED SAMPLE WAS FUNCTIONALLY TESTED IN ACCORDANCE WITH THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT. THE IFU STATES, "THREAD TAPERED TIP OF DILATOR/SHEATH/VALVE ASSEMBLY OVER SPRING WIRE GUIDE. GRASPING NEAR SKIN, ADVANCE ASSEMBLY WITH SLIGHT TWISTING MOTION TO A DEPTH SUFFICIENT TO ENTER VESSEL. DILATOR MAY BE PARTIALLY WITHDRAWN TO FACILITATE ADVANCEMENT OF SHEATH THROUGH TORTUOUS VESSEL". A LAB INVENTORY GUIDE WIRE WITH A DIAMETER OF .035" WAS INSERTED THROUGH THE RETURNED DILATOR. LITTLE TO NO RESISTANCE WAS OBSERVED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE, DILATOR, OR SHEATH. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, A CHEST X-RAY SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE IFU ALSO STATES, "DO NOT WITHDRAW DILATOR UNTIL SHEATH IS WELL WITHIN VESSEL TO MINIMIZE THE RISK OF DAMAGE TO SHEATH TIP". THE CUSTOMER REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS FRAYED AND OVULAR. DESPITE THIS, THE SAMPLE PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL TESTING. BASED THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED DURING USE AND THE DAMAGE OBSERVED ON THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED SHEATH ACCORDIONED AT THE TRANSITION OF DILATOR AND SHEATH.ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHEATH ACCORDIONED AT THE TRANSITION OF DILATOR AND SHEATH. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429974 ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL INTRODUCER CATHETER DYB ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1