BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 1863062 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00770
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 22, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE IN HALF WHILE USING A UNIVERSAL SLITTER. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN SELECT II LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. 6248DEL130 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention