BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB

    MDR report key: 16590624 · Received March 22, 2023

    Report

    Report Number
    9680794-2023-00201
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 19, 2023
    Report Date
    February 23, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. THE CUSTOMER RETURNED ONE DILATOR FOR ANALYSIS. S IGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE DILATOR BODY. VISUAL ANALYSIS REVEALED WIDENING DIRECTLY AT THE DISTAL TIP OF THE DILATOR. WHITE STRESS MARKS WERE OBSERVED AROUND THIS DEFECTIVE AREA, WHICH IS AN INDICATOR THAT EXCESSIVE FORCE CONTRIBUTED TO THE DAMAGE. WHEN COMPARED TO A LAB INVENTORY DILATOR, NO OBVIOUS DIFFERENCES IN STRUCTURAL INTEGRITY WERE OBSERVED. THE DILATOR LENGTH FROM THE HUB TO THE TIP MEASURED 3 15/16" VIA CALIBRATED RULER, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3 3/4"-4 1/14" PER THE DILATOR PRODUCT DRAWING. THE DILATOR OUTER DIAMETER MEASURED 0.111" VIA CALIBRATED MICROMETER, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.111"-0.113" PER THE DILATOR EXTRUSION PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE PROXIMAL END MEASURED 0.064" VIA CALIBRATED PIN GAUGE, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.064"-0.067" PER THE DILATOR EXTRUSION PRODUCT DRAWING. FUNCTIONAL INSPECTION WAS PERFORMED PER IFU STATEMENT, "USE TISSUE DILATOR TO ENLARGE TISSUE TRACT TO THE VEIN AS REQUIRED. FOLLOW THE ANGLE OF THE GUIDEWIRE SLOWLY THROUGH THE SKIN". A LAB INVENTORY GUIDE WIRE WITH A DIAMETER OF 0.032" WAS INSERTED THROUGH THE DISTAL TIP OF THE DILATOR. LITTLE TO NO RESISTANCE WAS ENCOUNTERED AS THE GUIDE WIRE PASSED COMPLETELY THROUGH THE DILATOR WITH LITTLE TO NO RESISTANCE. THE DILATOR WAS SENT FOR ADDITIONAL ANALYSIS, AND IT WAS CONFIRMED THAT THE DILATOR TIP INNER DIAMETER AT THE TIP WAS INDEED FLARED. EXTENSIVE DIMENSIONAL ANALYSIS WAS PERFORMED ON THE DILATOR, AND IT WAS NOTED THAT THERE IS VARIATION IN THE TIP RADIUS; HOWEVER, IT WAS CONCLUDED THAT THIS IS A RESULT OF THE FLARING/DISTORTION DURING USE OF THE DEVICE. IN SUMMARY, THE FLARING OF THE TIP RADIUS AND THICKNESS IS A RESULT OF DEFORMATION CAUSED DURING INSERTION. ADDITIONALLY, THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, 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: DILATOR ATTEMPTED TO BE PLACED, BUT THE END OF THE DILATOR FLARED. THE TIP IS "WAY TOO FLIMSY." NO PATIENT INFORMATION OR FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: DILATOR ATTEMPTED TO BE PLACED, BUT THE END OF THE DILATOR FLARED. THE TIP IS "WAY TOO FLIMSY." NO PATIENT INFORMATION OR FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450580 ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB CATHETER,INTRAVASCULAR,THERAPE FOZ ARROW INTERNATIONAL LLC 13F22J0500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED.| NOT REPORTED.