BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPONADE URETERINE BALLOON CATHETER SET

    MDR report key: 928726 · Received October 16, 2007

    Report

    Report Number
    1825146-2007-00019
    Event Type
    Injury
    Date Received
    October 16, 2007
    Date of Event
    September 2, 2007
    Manufacturer
    COOK UROLOGICAL
    Product Code
    KNA
    PMA / PMN Number
    K103597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVALUATION CANNOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED; THE CUSTOMER INDICATED THE PRODUCT WAS THROWN OUT. THE PATIENT WAS NOTED TO HAVE HAD AN UNCOMPLICATED VAGINAL DELIVERY 23 DAYS PRIOR. THE CUSTOMER STATED THE PATIENT ARRIVED IN THE EMERGENCY ROOM AFTER PASSING A BLOOD CLOT THE SIZE OF A GRAPEFRUIT AT HOME. SHE WAS THEN MOVED TO LABOR AND DELIVERY AND A DILATATION AND CURETTAGE WAS PERFORMED USING A LARGE HUNTER CURRETTE. THE BAKRI BALLOON WAS THEN PLACED BY A JUNIOR RESIDENT UNDER THE GUIDANCE OF DR. DR DID NOT FEEL THERE WAS ANY UNDUE OR GREAT FORCE USED TO INSERT THE BALLOON. THE RESIDENT THEN HELD IT IN PLACE WHILE DR INFLATED THE BALLOON USING AMBIENT ATMOSPHERE, ROUGHLY 500-600CC. THE INFORMATION FOR USE BOOKLET, WHICH IS AFFIXED TO THE BACK OF THE PACKAGE, HAS A WARNING STATING TO ALWAYS INFLATE THE BALLOON WITH STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. THE PATIENT WAS NOTED AT THAT TIME TO HAVE A GREAT DEAL OF BRISK BLEEDING AND TWO UNITS OF BLOOD WERE GIVEN IMMEDIATELY. WITHIN ABOUT ONE HOUR TO TWO HOURS AFTER THE PROCEDURE THAT PATIENT WAS NOTED TO HAVE A LARGER AMOUNT OF BLEEDING AROUND THE BALLOON. FURTHER BLOODS WERE GIVEN AND THE DECISION MADE TO TAKE THE PATIENT TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY AND POSSIBLE SUPRACERVICAL HYSTERECTOMY. THE MIDLINE WAS OPEN WITH ABOUT 100ML OF CLOTTED BLOOD SEEN IN THE PELVIS AS WELL AS THE TIP OF THE BALLOON WAS EXTRUDING FROM THE LATERAL PORTION OF THE UTERINE BODY ABOVE THE UTEROCERVICAL JUNCTION. THE CATHETER TIP IS ATRAUMATIC IN NATURE AND THE TIP NORMALLY "SINKS" INTO THE BALLOON BODY. THE ABDOMEN WAS EXPLORED WITH THE OUTCOME BEING A HYSTERECTOMY BEING PERFORMED. AT THIS TIME, WE ARE UNABLE TO DETERMINE WHAT HAS CAUSED THE PERFORATION OF THE UTERINE WALL. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED. ADD'L PMA 510(K) IS K062438.

    Description of Event or Problem · 1

    CUSTOMER STATES: "THE BALLOON PERFORATED THE LOWER URTERINE CERVICAL JUNCTION. HYSTERECTOMY WAS PERFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPONADE URETERINE BALLOON CATHETER SET BAKRI POSTPARTUM BALLOON KNA COOK UROLOGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention