BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET

    MDR report key: 6427348 · Received March 23, 2017

    Report

    Report Number
    6427348
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 17, 2017
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    HES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTORS WERE PERFORMING A HYSTEROSALPINGOGRAM IN RADIOLOGY. THE DISPOSABLE CATHETER WAS DEFECTIVE - BALLOON WAS NOT INFLATING PROPERLY AND CONTRAST FLUID LEAKED OUT OF THE PATIENT'S VAGINA RATHER THAN INTO THE FALLOPIAN TUBES. THE SECOND DISPOSABLE CATHETER WAS ALSO DEFECTIVE - BALLOON POPPED (DURING TESTING PRIOR TO INSERTION) IMMEDIATELY UPON INFLATION, THUS RENDERING THE EXAM INCOMPLETE. THE PROCEDURE WAS CANCELLED AND WOULD NEED TO BE REPEATED AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209135 ROCKET SONOHYSTOGRAM CATHETER HES ROCKET MEDICAL PLC R57422 468380

    Patients

    Seq Age Sex Outcome Treatment
    1