BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-1/2 IN

    MDR report key: 25278252 · Received May 26, 2026

    Report

    Report Number
    9680794-2026-00410
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 29, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    UDI-DI
    00801902002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE GUIDEWIRE (LOOSE) UNRAVELED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED FOLLOWING REPLACEMENT WITH ANOTHER DEVICE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146582 ARROW RA CATH SET: 20 GA X 1-1/2 IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC 14F24B0286 00801902002761

    Patients

    Seq Age Sex Outcome Treatment
    1