BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1230861 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05531
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING, THE CRE 18MM X 20MM BALLOON DILATATION CATHETER FROM ITS PACKAGING, A SHAFT KINK WAS NOTED. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE KINK, BUT WAS UNSUCCESSFUL. THE DEVICE WAS NOT USED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558380 9450309

    Patients

    Seq Age Sex Outcome Treatment
    1