BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 22 GA X 1-3/8IN

    MDR report key: 24886088 · Received April 15, 2026

    Report

    Report Number
    9680794-2026-00318
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    00801902002754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "GUIDEWIRE ARE KINKED DURING THE DIAGNOSTIC". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158872 ARROW RA CATH SET: 22 GA X 1-3/8IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC 14F25B0032 00801902002754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED