BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TRAY

    MDR report key: 3042374 · Received March 8, 2013

    Report

    Report Number
    1036844-2013-00083
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED VIA MEDWATCH REPORT. IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) FEMALE PT. THE DOCTOR WAS INSERTING THE ARTERIAL CATHETER IN THE RIGHT FEMORAL ARTERY. THE INITIAL ATTEMPT TO ADVANCE THE GUIDE WIRE WAS UNSUCCESSFUL AND WHEN IT WAS REMOVED THE END OF IT WAS SHREDDED. A SECOND GUIDE WIRE WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100584 ACCESS TRAY ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. RF2022502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR