BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON UTERINE STENT

    MDR report key: 1841211 · Received September 10, 2010

    Report

    Report Number
    1825146-2010-00035
    Event Type
    Injury
    Date Received
    September 10, 2010
    Report Date
    September 9, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    KNA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, THE PHYSICIAN HAS RESPONDED: I USED THE BALLOON UTERINE STENT TO KEEP THE UTERINE CAVITY DISTENDED FOR SEVERAL DAYS AFTER RESECTION OF UTERINE SYNECHIAE. THIS PROBABLY WAS NOT THE INTENDED USE OF THE DEVICE, BUT ITS SHAPE, WHICH MIMICS THE UTERINE CAVITY, TEMPTED ME TO USE IT FOR THIS PURPOSE. REGRETFULLY THERE IS NOT YET A DEVICE DESIGNED FOR THIS PARTICULAR NEED. INTENDED USE FOR THIS PRODUCT: USED FOR PLACEMENT IN THE UTERUS FOLLOWING AN INTRAUTERINE SURGICAL PROCEDURE IN ORDER TO REDUCE UTERINE BLEEDING. WITH A CONTRAINDICATION: USE OF THIS DEVICE IS CONTRAINDICATED IN THE PRESENCE OF PREGNANCY, CERVICAL CANCER, PURULENT INFECTIONS IN THE VAGINA, CERVIX OR UTERUS, UNTREATED UTERINE ANOMALY, OR A SURGICAL SITE WHICH WOULD PROHIBIT THE DEVICE FROM EFFECTIVELY CONTROLLING BLEEDING. ALSO A CAUTION: DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN 24 HOURS. THE DEVICE WAS NOT USED AS RECOMMENDED IN REGARD TO THE TYPE OF PROCEDURE ALONG WITH THE AMOUNT OF TIME THE BALLOON WAS LEFT INDWELLING.

    Description of Event or Problem · 1

    WHEN THE PATIENT CAME TO DOCTOR OFFICE FOR THE BALLOON TO BE REMOVED, IT WOULD NOT COME OUT AND HE PULLED ON THE END OF THE CATHETER AND IT BROKE OFF OF THE BALLOON PORTION WHICH WAS STILL INSIDE THE PATIENT. IN ORDER TO RETRIEVE THE DEVICE, HE HAD TO TAKE THE PATIENT TO THE OPERATING ROOM AND PROVIDE HER WITH ANESTHESIA AND THEN DILATE HER SO HE COULD REMOVE THE BALLOON. DOCTOR STATES THAT HE ALSO HAD DIFFICULTY PLACING THE PRODUCT IN THE PATIENT. THE PHYSICIAN LEFT THE PRODUCT IN THE PATIENT MUCH LONGER THAN THE IFY RECOMMENDS. HE LEFT IT INDWELLING FOR 36 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON UTERINE STENT KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC KNA COOK UROLOGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention