BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER OCCLUSION BALLOON CATHETER

    MDR report key: 3964276 · Received June 19, 2014

    Report

    Report Number
    2032493-2014-00057
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE DISTAL END OF THE DEVICE REMOVED AND NOT RETURNED FOR EVAL AS IT REMAINS WITHIN THE PT. THE RETURNED PORTION OF THE DEVICE APPEARED NORMAL IN APPEARANCE. NO ABNORMALITIES WERE IDENTIFIED. THE ROOT CAUSE OF THE DEVICE BREAKING IS DUE TO THE DEVICE BECOMING STUCK. IT IS UNK IF THE BALLOON BECAME GLUED IN THE PT DUE TO THE ANATOMY OR THE ONYX REFLUXING AROUND THE CATHETER. THE DEVICE HISTORY RECORDS WERE REVIEWED. NO DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED WITHIN THESE BUILDS.

    Description of Event or Problem · 1

    DURING THE TREATMENT OF A TUMOR EMBOLIZATION WITH TORTUROUS ANATOMY, THE CATHETER BROKE UPON WITHDRAWAL FOLLOWING THE ONYX INJECTION. THE DISTAL PORTION OF THE CATHETER REMAINED WITHIN THE PT. NO INTERVENTION WAS TAKEN. NO HARM WAS REPORTED. THE PT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360899 SCEPTER OCCLUSION BALLOON CATHETER BALLOON CATHETER MJN MICROVENTION, INC. BC0411XC 13120321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other