BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 20013040 · Received August 21, 2024

    Report

    Report Number
    3006425876-2024-00815
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    June 29, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    00801902102362
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE WITHIN ITS ADVANCER FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE GUIDE WIRE. VISUAL ANALYSIS REVEALED THE GUIDE WIRE HAD TWO KINKS TOWARDS THE CENTER OF THE BODY. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDE WIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. VISUAL ANALYSIS OF THE ARS COULD NOT BE PERFORMED WITHOUT THE ARS RETURNED. THE KINKS IN THE GUIDE WIRE WERE LOCATED 376 MM AND 397 MM FROM THE PROXIMAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 602 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 596-604 MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.795 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.788-0.826 MM PER GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS-FOR-USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE." THE GUIDE WIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDE WIRE. THE UNDAMAGED PORTIONS OF THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH LITTLE TO NO RESISTANCE. FUNCTIONAL ANALYSIS OF THE ARS COULD NOT BE PERFORMED WITHOUT THE ARS RETURNED. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION , "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED , RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE HAD TWO KINKS TOWARDS THE CENTER OF THE BODY. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL/FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE ERROR LIKELY CONTRIBUTED TO THIS EVENT, HOWEVER, THE PROBABLE CAUSE OF GUIDE WIRE AND ARS RESISTANCE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ARS BEING RETURNED FOR EVALUATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE SWG/ARS RESISTANCE DURING USE ON THE PATIENT INVOLVED 1 PC." THEY CHANGED TO A NEW ONE. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354172 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F23B1441 00801902102362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED