BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PSI SET: 8.5 FR

    MDR report key: 13994657 · Received April 4, 2022

    Report

    Report Number
    9680794-2022-00202
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 11, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING A DILATOR. VISUAL ANALYSIS REVEALED THAT THE DILATOR BODY WAS SEVERELY KINKED IN THE MIDDLE OF THE EXTRUSION. THE CUSTOMER RETURNED ONE DILATOR AND LIDSTOCK FOR ANALYSIS. NO DEFINITE SIGNS OF USE WERE OBSERVED. THE SHEATH WAS NOT RETURNED FOR ANALYSIS. THEREFORE, IT CANNOT BE CONFIRMED IF SIMILAR DAMAGE WAS PRESENT ON THE SHEATH. VISUAL ANALYSIS REVEALED THAT THE RETURNED DILATOR WAS SEVERELY KINKED/BENT IN THE MIDDLE OF THE EXTRUSION. WHITE STRESS MARKS WERE OBSERVED AROUND THE DAMAGE , WHICH INDICATES THAT UNDUE FORCE CAUSED OR CONTRIBUTED TO THIS EVENT. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE KINK IN THE DILATOR MEASURED 71MM FROM THE DILATOR HUB. THE DILATOR TOTAL LENGTH FROM THE HUB TO THE DISTAL TIP MEASURED 6 7/8" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 6 5/8"-7 1/8" PER THE DILATOR PRODUCT DRAWING. THE DILATOR OUTER DIAMETER MEASURED .111" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .111"-.113" PER THE DILATOR EXTRUSION PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE PROXIMAL END MEASURED .063" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .063"-.067" PER THE DILATOR EXTRUSION PRODUCT DRAWING. A LAB INVENTORY GUIDE WIRE WITH A DIAMETER OF .035" WAS INSERTED THROUGH BOTH THE PROXIMAL AND DISTAL ENDS OF THE DILATOR. MAJOR RESISTANCE WAS ENCOUNTERED AT THE LOCATION OF THE BEND. NO OTHER BLOCKAGES WERE OBSERVED. PERFORMED PER IFU STATEMENT "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 DILATOR MAY BE PARTIALLY WITHDRAWN TO FACILITATE ADVANCEMENT OF SHEATH THROUGH TORTUOUS VESSEL". MANUFACTURING WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT THE DEFECT IS NOT CONSISTENT WITH DEFECTS OCCURRING DURING THE EXTRUSION PROCESS. ALL DILATORS ARE 100% INSPECTED FOR ANY DEFECTS PRIOR TO RELEASE. ADDITIONALLY, ALL DILATORS ARE FUNCTIONALLY TESTED TO ENDURE THERE ARE NO INTERNAL BLOCKAGES. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT WITHDRAW DILATOR UNTIL THE SHEATH IS WELL WITHIN THE VESSEL TO PREVENT DAMAGE TO SHEATH TIP". THE REPORT OF A DAMAGED DILATOR WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE DILATOR WAS KINKED IN THE MIDDLE OF THE EXTRUSION. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED WHITE STRESS MARKS. THE DILATOR MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT THAT THE DEFECT OCCURRED DURING USE AND THE COMMENTS FROM THE MANUFACTURING FACILITY, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS "AT THE MOMENT OF BEING USED, THE SPLIT DILATOR IS PRESENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS "AT THE MOMENT OF BEING USED, THE SPLIT DILATOR IS PRESENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498590 ARROW PSI SET: 8.5 FR INTRODUCER, CATHETER DYB ARROW INTERNATIONAL LLC 14F19J0103

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female N/A.| N/A.