BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH. SET: 22 GA X 5CM

    MDR report key: 20775213 · Received November 25, 2024

    Report

    Report Number
    3006425876-2024-01178
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902129830
    PMA / PMN Number
    K171146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE GUIDEWIRE FROM AN ARTERIAL CATHETERIZATION SET ALONG WITH ITS LIDSTOCK FOR EVALUATION. VISUAL ANALYSIS REVEALED SIGNS OF USE ALONG THE GUIDEWIRE. SEVERAL KINKS AND BENDS WERE PRESENT. THE DAMAGE ON THE GUIDEWIRE SUGGESTS THE GUIDEWIRE WAS KINKED DURING USE. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. THE KINKS ON THE GUIDEWIRE WERE MEASURED AT 22MM AND 176MM FROM THE PROXIMAL TIP. A SLIGHT BEND WAS MEASURED AT 322MM FROM THE PROXIMAL TIP. THE GUIDEWIRE LENGTH MEASURED 350MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 345MM - 355MM PER GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE OUTER DIAMETER MEASURED 0.51MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.508MM - 0.533MM PER GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "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 CATHETER/ NEEDLE ASSEMBLY IS USED , REMOVE NEEDLE AND INSERT GUIDEWIRE THROUGH CATHETER INTO ARTERY AS DESCRIBED ABOVE. IF "J" TIP GUIDEWIRE IS USED, PREPARE FOR INSERTION BY SLIDING STRAIGHTENING TUBE OVER "J" TO STRAIGHTEN AND ADVANCE GUIDEWIRE TO REQUIRED DEPTH." THE GUIDEWIRE WAS ADVANCED THROUGH A LAB INVENTORY INTRODUCER NEEDLE AND THE UNDAMAGED PORTIONS WERE ABLE TO PASS WITH LITTLE TO NO RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS THE USER , "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL.". THE CUSTOMER REPORT OF A KINKED GUIDEWIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. KINKS AND BENDING WERE OBSERVED ON THE GUIDEWIRE BODY. DESPITE THIS, THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CONDITION OF THE GUIDEWIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE , UNINTENTIONAL USE ERROR 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 "THE GUIDE IS BENT". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

    Description of Event or Problem · 0

    IT WAS REPORTED "THE GUIDE IS BENT". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CO NDITION IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735634 ARROW ARTERIAL CATH. SET: 22 GA X 5CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F24F0030 10801902129830

    Patients

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