BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN/PSI SET

    MDR report key: 19804567 · Received July 23, 2024

    Report

    Report Number
    3006425876-2024-00724
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    00801902102898
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE MAC WITH DILATOR, A GUIDE WIRE, AND A LIDSTOCK FOR ANALYSIS. THE GUIDE WIRE WAS INSERTED THROUGH THE DILATOR. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE GUIDE WIRE SURFACE. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS KINKED IN TWO LOCATIONS. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. FURTHER ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES ON THE RETURNED DILATOR NOR THE MAC. THE KINKS ON THE GUIDE WIRE MEASURED 250MM AND 340MM FROM THE PROXIMAL WELD. THE GUIDE WIRE LENGTH MEASURED 455MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450MM-458MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER MEASURED 0.84MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838MM-0.877MM PER THE GUIDE WIRE PRODUCT DRAWING. THE DILATOR LENGTH MEASURED 8 1/8", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8 1/32"-8 9/32" PER THE DILATOR PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE DISTAL END MEASURED 0.036", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.036"-0.038" PER THE DILATOR PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE PROXIMAL END MEASURED 1.3208MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 1.30MM-1.40MM PER THE DILATOR EXTRUSION PRODUCT DRAWING. THE FUNCTIONAL END OF THE GUIDE WIRE WAS INSERTED THROUGH THE DISTAL TIP OF THE RETURNED DILATOR. LITTLE TO NO RESISTANCE WAS ENCOUNTERED THROUGHOUT THE FUNCTIONAL SECTION OF THE GUIDE WIRE. IT PASSED COMPLETELY THROUGH THE DILATOR EXTRUSION. PERFORMED PER IFU STATEMENT, "THREAD TAPERED TIP OF DILATOR/ACCESS DEVICE ASSEMBLY OVER GUIDEWIRE. SUFFICIENT GUIDEWIRE LENGTH MUST REMAIN EXPOSED AT HUB END OF DEVICE TO MAINTAIN A FIRM GRIP ON GUIDEWIRE". 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 APPLY EXCESSIVE FORCE IN PLACING OR REMOVING GUIDEWIRE, DILATOR, OR ACCESS DEVICE. 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 OF A KINKED GUIDE WIRE DUE TO DILATOR RESISTANCE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS KINKED IN TWO LOCATIONS. DESPITE THE DAMAGE, THE GUIDE WIRE AND DILATOR MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY 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

    IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND GUIDE WIRE DEFECT (WIRE BENDING PHENOMENON OCCURS). SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND GUIDE WIRE DEFECT (WIRE BENDING PHENOMENON OCCURS). SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935816 ARROW MULTILUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC 71F23G0716 00801902102898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED| NONE REPORTED