BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 3862627 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00597
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K123153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END VALVE PIECE IN THE CATHETER WAS UPSIDE DOWN. THE CATHETER WAS USED FOR THE PROCEDURE. THE PHYSICIAN PULLED THE VALVE OFF AND CUT THE SHEATH WITH THE SLITTER UPON COMPLETION OF THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340778 ATTAIN COMMAND CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250V-MP 0007018962

    Patients

    Seq Age Sex Outcome Treatment
    1