BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN CVC KIT: 2-L 8 FR X 6" (16 C

    MDR report key: 14312863 · Received May 6, 2022

    Report

    Report Number
    9680794-2022-00266
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE AND LIDSTOCK FOR ANALYSIS. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THREE DISTINCT KINKS ACROSS THE GUIDE WIRE BODY. THIS RESULTED IN THE DISTAL J-BEND TO BE SLIGHTLY MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SPHERICAL AND INTACT. THE KINKS IN THE GUIDE WIRE MEASURED 25MM, 167MM, AND 175MM FROM THE DISTAL WELD. THE GUIDE WIRE TOTAL LENGTH MEASURED 457MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450M-458MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER MEASURED .790MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF .788MM-.826MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS INSERTED THROUGH A LAB INVENTORY ARROW RAULERSON SYRINGE (ARS)/INTRODUCER NEEDLE SUBASSEMBLY. THE GUIDE WIRE MET SIGNIFICANT RESISTANCE DUE TO THE KINKING. THE NON-DAMAGED PORTION OF THE GUIDE WIRE WAS INSERTED THROUGH THE ARS/INTRODUCER NEEDLE, AND IT APPEARED TO PASS WITH LITTLE TO NO DIFFICULTY. PERFORMED PER IFU STATEMENT "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE". A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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". THE REPORT OF A KINKED GUIDE WIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS KINKED IN THREE LOCATIONS. DESPITE THIS, THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. 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 GUIDEWIRE WAS KINKING ON THREE KITS IN A ROW ON THE SAME PATIENT. ANESTHESIA TRIED TWO TIMES WITH TWO KITS, THE PHYSICIAN TRIED THE THIRD TIME WITH THE THIRD KIT. IT WAS REPORTED THERE WAS A DELAY IN THERAPY WITHOUT HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE GUIDEWIRE WAS KINKING ON THREE KITS IN A ROW ON THE SAME PATIENT. ANESTHESIA TRIED TWO TIMES WITH TWO KITS, THE PHYSICIAN TRIED THE THIRD TIME WITH THE THIRD KIT. IT WAS REPORTED THERE WAS A DELAY IN THERAPY WITHOUT HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098925 ARROW MULTI-LUMEN CVC KIT: 2-L 8 FR X 6" (16 C CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC 13F21L0196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown