BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 18 GA X 16CM

    MDR report key: 18254877 · Received December 4, 2023

    Report

    Report Number
    3006425876-2023-01179
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902129939
    PMA / PMN Number
    K171146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER REPORT OF A GUIDE WIRE KINKED IN USE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE ARTERIAL GUIDE WIRE AND THE PRODUCT LIDSTOCK FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER REVEALED A KINK AND A GRADUAL BEND NEAR THE DISTAL END. THE DISTAL J BEND WAS MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE. BOTH WELDS WERE PRESENT AND OBSERVED TO BE FULL AND SPHERICAL. THE KINK IN THE GUIDE WIRE MEASURED 15MM VIA CALIBRATED RULER FROM THE DISTAL END. THE GUIDE WIRE TOTAL LENGTH MEASURED 456MM, WHICH IS WITHIN THE SPECIFICATIONS OF 450-458MM PER PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER (OD) MEASURED 0.62MM VIA CALIBRATED CALIPER WHICH WAS WITHIN THE SPECIFICATIONS OF 0.610-0.635MM PER PRODUCT DRAWING. FUNCTIONAL INSPECTION OF THE GUIDE WIRE WAS PERFORMED PER THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT WHICH STATES, "INSERT TIP OF GUIDEWIRE THROUGH INTRODUCER NEEDLE INTO ARTERY (UNTIL DEPTH-MARKING [IF PROVIDED] ON WIRE ENTERS HUB OF NEEDLE). AT THIS POINT, THE DEPTH-MARKING ENTERING HUB SHOWS THAT TIP OF WIRE LEAVES TIP OF INTRODUCER NEEDLE AND ENTERS VESSEL. IF "J" TIP GUIDEWIRE IS USED, PREPARE FOR INSERTION BY SLIDING STRAIGHTENING TUBE OVER "J" TO STRAIGHTEN AND ADVANCE GUIDEWIRE TO REQUIRED DEPTH." THE UNDAMAGED PORTION OF THE GUIDE WIRE WAS THREADED THROUGH A LAB INVENTORY 20GA INTRODUCER NEEDLE WITH NO RESISTANCE. A MANUAL TUG TEST CONFIRMED THE DISTAL AND PROXIMAL WELDS WERE INTACT. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT WARNS THE USER, "PRECAUTION: USE CARE WHEN REMOVING GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED, REMOVE GUIDEWIRE AND CATHETER TOGETHER AS A UNIT. USE OF EXCESSIVE FORCE MAY DAMAGE CATHETER OR GUIDEWIRE." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). IN SECTION D PROVIDED THE FULL UDI #. UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " THE DOCTOR INSERTED AN ARTERIAL CATHETER AND THE GUIDE KINKED, SO HE HAD TO USE A NEW SET. THIS RESULTED IN A WASTE OF TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " THE DOCTOR INSERTED AN ARTERIAL CATHETER AND THE GUIDE KINKED, SO HE HAD TO USE A NEW SET. THIS RESULTED IN A WASTE OF TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE DOCTOR INSERTED AN ARTERIAL CATHETER AND THE GUIDE KINKED, SO HE HAD TO USE A NEW SET. THIS RESULTED IN A WASTE OF TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429258 ARROW ARTERIAL CATH SET: 18 GA X 16CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN920505 71F22H2037 10801902129939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.| NOT REPORTED.