BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 20198127 · Received September 12, 2024

    Report

    Report Number
    3006425876-2024-00932
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    July 18, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    00801902100207
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE PHOTO DISPLAYED THE GUIDE WIRE ASSEMBLY AND ARS/18GA INTRODUCER NEEDLE SUBASSEMBLY. KINKING/BENDING OF THE GUIDE WIRE WAS CONFIRMED IN THE RETURNED PHOTO. THE CUSTOMER ALSO RETURNED ONE GUIDE WIRE ASSEMBLY AND ARROW RAULERSON SYRINGE (ARS)/18GA INTRODUCER NEEDLE SUBASSEMBLY FOR ANALYSIS. DEFINITE EVIDENCE OF USE WAS OBSERVED. VISUAL ANALYSIS OF THE GUIDE WIRE REVEALED MULTIPLE KINKS ALONG THE BODY. VISUAL ANALYSIS OF THE ARS REVEALED NO OBVIOUS DEFECTS OR ANOMALIES. MICROSCOPIC EXAMINATION REVEALED THAT THE GUIDE WIRE WELDS WERE PRESENT AND SPHERICAL. THE CUSTOMER WAS CONSULTED TO PROVIDE CLARIFICATION OF THE GUIDE WIRE CONDITION. IT WAS CONFIRMED THAT NO DAMAGE WAS IDENTIFIED PRIOR TO USE; THEREFORE, THE KINKING IS LIKELY CORRELATED WITH THE RESISTANCE EXPERIENCED BY THE CUSTOMER DURING USE. THE MAJOR KINKS IN THE GUIDE WIRE MEASURED 320 AND 340MM FROM THE PROXIMAL END. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 685MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 678- 688MM PER THE GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.849MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838-0.877MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS TESTED THE RETURNED ARS/18GA INTRODUCER NEEDLE SUBASSEMBLY PER THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT. THE IFU STATES, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE". THE UNDAMAGED PORTION OF THE GUIDE WIRE WAS ABLE TO PASS THROUGH THE ARS WITH LITTLE TO NO ISSUES. MINOR RESISTANCE WAS EXPERIENCED AT THE KINKS. A MANUAL TUG TEST CONFIRMED THAT BOTH WELDS WERE SECURE. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS PART OF THIS COMPLAINT INVESTIGATION. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "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 CUSTOMER REPORT OF RESISTANCE BETWEEN THE ARS AND GUIDE WIRE COULD NOT BE CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS OF THE GUIDE WIRE REVEALED THAT IT WAS KINKED, WHICH IS LIKELY CORRELATED WITH THE CUSTOMER REPORT OF RESISTANCE BETWEEN THE ARS AND GUIDE WIRE. DESPITE THIS, THE GUIDE WIRE PASSED ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND THE UNDAMAGED PORTION OF THE GUIDE WIRE PASSED THE ARS WITH NO ISSUES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "18 JULY 2024, THE DOCTOR FOUND THE SWG / ARS RESISTANCE DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT CONDITION IS FINE. INVOLVED 1 PC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478900 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F23H0426 00801902100207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown