BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBRYON ECOCATH TRIAL CATHETER SYSTEM

    MDR report key: 838804 · Received April 2, 2007

    Report

    Report Number
    MW1042552
    Event Type
    Injury
    Date Received
    April 2, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 28, 2007
    Manufacturer
    ROCKET MED
    Product Code
    MQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN PREPARATION FOR EMBRYO TRANSFER, THE DEVICE WAS INSERTED THROUGH THE CERVIX TO THE UPPER UTERINE CAVITY UNDER ULTRASOUND GUIDANCE. THE OUTER PORTION OF THE DEVICE WAS HELD IN PLACE WHILE THE INNER PORTION WAS WITHDRAWN. ON REMOVAL, THE INNER PORTION WAS NOTED TO BE MISSING THE ECHOGENIC METAL RING AND THE METAL COULD BE SEEN ON ULTRASOUND TO BE PRESENT WITHIN THE UTERINE CAVITY. THE METAL REMAINED IN PLACE WHEN THE REMAINDER OF THE DEVICE (THE OUTER SHEATH) WAS ALSO REMOVED. THE METAL RING WAS RETRIEVED LATER THAT DAY WITH CERVICAL ANESTHESIA AND DILATATION, USING ULTRASOUND TO GUIDE AN ENDOMETRIAL ASPIRATION PIPETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBRYON ECOCATH TRIAL CATHETER SYSTEM TRIAL UTERINE EMBRYO TRANSFER CATHETER MQF ROCKET MED R57631-EC-18 407194

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention