BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 4 FR X 5 CM

    MDR report key: 21558723 · Received March 10, 2025

    Report

    Report Number
    3006425876-2025-00243
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 20, 2025
    Report Date
    February 20, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    30801902124310
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER PROVIDED ONE IMAGE FOR ANALYSIS. THE IMAGE SHOWS AN UNRAVELED GUIDEWIRE BEING HELD IN A GLOVE. THE CUSTOMER COMPLAINT OF AN UNRAVELED SWG DURING USE WAS CONFIRMED BY THE CUSTOMER-PROVIDED IMAGE. THE CUSTOMER ALSO RETURNED ONE CATHETER FOR EVALUATION. THE GUIDEWIRE WAS NOT RETURNED. VISUAL EXAMINATION OF THE CATHETER REVEALED OBVIOUS SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED WITH THE CATHETER. VISUAL ANALYSIS OF THE GUIDEWIRE COULD NOT BE COMPLETED SINCE IT WAS NOT RETURNED. DIMENSIONAL ANALYSIS OF THE GUIDEWIRE COULD NOT BE PERFORMED AS IT WAS NOT RETURNED FOR ANALYSIS. THE OVERALL LENGTH OF THE CATHETER BODY MEASURED 2 1/16", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 1 25/32" - 2 3/16" PER THE CATHETER PRODUCT DRAWING. THE DISTAL EXTENSION LINE OUTER DIAMETER MEASURED 0.08581", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.084" - 0.088" PER THE DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE DISTAL EXTENSION LINE INNER DIAMETER MEASURED 0.05650", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.055" - 0.059" PER THE DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE PROXIMAL EXTENSION LINE OUTER DIAMETER MEASURED 0.0865", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.084" - 0.088" PER THE PROXIMAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE PROXIMAL EXTENSION LINE INNER DIAMETER MEASURED 0.0571", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.055" - 0.059" PER THE PROXIMAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. FUNCTIONAL INSPECTION COULD NOT BE PERFORMED AS THE GUIDEWIRE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT INFORMS THE USER, "WARNING: DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE, DILATOR, OR SHEATH. " THE REPORT OF AN UNRAVELED GUIDEWIRE WAS CONFIRMED THROUGH VISUAL ANALYSIS OF THE CUSTOMER-PROVIDED IMAGE, HOWEVER, THE GUIDEWIRE WAS NOT RETURNED AS PART OF THIS COMPLAINT INVESTIGATION. THE CUSTOMER ONLY RETURNED ONE CATHETER. VISUAL ANALYSIS OF THE CATHETER DID NOT REVEAL ANY DEFECTS OR ANOMALIES. ADDITIONALLY, THE CATHETER MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND WITHOUT THE GUIDEWIRE RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING INSERTION, THE DOCTOR FOUND THE SWG UNRAVELLED DURING USED ON THE PATIENT. THE CATHETER 5CM SIDE HOLE WAS FOUND BLOCK DURING USED ON THE PATIENT." THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00243 AND 3006425876-2025-00242.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING INSERTION, THE DOCTOR FOUND THE SWG UNRAVELLED DURING USED ON THE PATIENT. THE CATHETER 5CM SIDE HOLE WAS FOUND BLOCK DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00242.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254336 ARROW CVC SET: 2-LUMEN 4 FR X 5 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F23J1322 30801902124310

    Patients

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