BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI KIT: 9FR X 4" (10 CM)

    MDR report key: 10413559 · Received August 17, 2020

    Report

    Report Number
    9680794-2020-00340
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 7, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K011761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER PROVIDED THREE PHOTOS OF A DILATOR TIP. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS DEFECTIVE. THE CUSTOMER ALSO RETURNED ONE DILATOR FOR ANALYSIS. NO DEFINITE SIGNS-OF-USE WERE OBSERVED. VISUAL INSPECTION OF THE DILATOR CONFIRMED THE TIP DAMAGE. THE TIP WAS DEFORMED AND FOLDED INWARD. THE TOTAL LENGTH OF THE DILATOR BODY WAS MEASURED TO BE 8.125", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8.031"-8.281" PER THE DILATOR GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .118", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR DISTAL INNER DIAMETER MEASURED .051", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.055" PER THE DILATOR GRAPHIC. A LAB INVENTORY GUIDE WIRE WITH THE SAME DIAMETER AS THE GUIDE WIRE PACKAGED WITHIN THE FINISHED KIT (.035") WAS INSERTED THROUGH THE DILATOR TIP. LITTLE TO NO RESISTANCE WAS OBSERVED. MANUFACTURING WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT THEY HAVE SEEN FAILURE MODES LIKE THIS BEFORE; HOWEVER, IT IS AN ISSUE LIKELY CAUSED BY THE CUSTOMER HANDLING OF THE DILATOR. IN ADDITION TO THIS, THEY ALSO PERFORM 100% VISUAL INSPECTION FOR THESE DILATORS. THE MANUFACTURING SITE INDICATED THAT THIS DEFECT IS CONSISTENT WITH THE DILATOR TIP COMING IN CONTACT WITH A SHARP OBJECT. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT WITHDRAW DILATOR UNTIL THE ACCESS DEVICE IS WELL WITHIN THE VESSEL TO MINIMIZE THE RISK OF DAMAGING TIP". THE CUSTOMER REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE DILATOR TIP WAS DEFORMED AND FOLDED INWARD. DESPITE THIS, THE DILATOR MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. BASED ON THE RETURNED SAMPLE, THE COMMENTS FROM MANUFACTURING, AND THE CUSTOMER PHOTOS, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT DURING INSERTION OF THE MAC CATHETER, THE USER HAD TROUBLE THREADING THE DILATOR OVER THE SPRING WIRE GUIDE. UPON INSPECTION OF THE DILATOR, THEY REALIZED THAT THE DISTAL TIP WAS DEFORMED. THE CUSTOMER REPORTS THAT THIS ISSUE WAS NOTED ON OTHER OCCASIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING INSERTION OF THE MAC CATHETER, THE USER HAD TROUBLE THREADING THE DILATOR OVER THE SPRING WIRE GUIDE. UPON INSPECTION OF THE DILATOR, THEY REALIZED THAT THE DISTAL TIP WAS DEFORMED. THE CUSTOMER REPORTS THAT THIS ISSUE WAS NOTED ON OTHER OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879687 ARROW MULTI-LUMEN/PSI KIT: 9FR X 4" (10 CM) CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1