BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F (EBU4.0)

    MDR report key: 1982390 · Received January 14, 2011

    Report

    Report Number
    1220452-2011-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE GUIDE CATHETER HUB FRACTURED DURING USE. PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUNCHER 6F (EBU4.0) DQY MEDTRONIC, INC. NA 0004890429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA