BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM BALLOON BS-4

    MDR report key: 11169616 · Received January 14, 2021

    Report

    Report Number
    3001722928-2021-00001
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 14, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BS-4 BALLOON IS NOT COMMERCIALLY AVAILABLE IN THE UNITED STATES. IT IS SIMILAR TO THE BS-2 BALLOON WHICH IS MARKETED UNDER K143556. USE OF A 10-ML SYRINGE CAN EASILY GENERATE A HIGHER PRESSURE THAN THE PRESSURE GENERATED BY THE BALLOON CONTROLLER, AND THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND BLEEDING WAS OBSERVED IMMEDIATELY AFTER PRESSURIZATION WITH THE SYRINGE. THEREFORE, THE CAUSE OF THE HEALTH DAMAGE IS CONSIDERED TO BE OVERPRESSURE DUE TO THE USE OF THE SYRINGE. THE BALLOON WAS NOT ATTACHED PROPERLY AND WAS DISPLACED DUE TO THE LOAD DURING THE PROCEDURE, AND THE DISPLACED BALLOON BLOCKED THE OPENING OF THE CHANNEL THAT SUPPLIES AIR INTO THE BALLOON, WHICH LED TO THE STATE WHERE THE SYRINGE COULD INCREASE PRESSURE BUT NOT DECREASE IT. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DOUBLE-BALLOON ENDOSCOPY WAS STARTED ON A PATIENT WITH CROHN'S DISEASE AND STRONG SMALL INTESTINAL ADHESIONS. THE BALLOON BS-4 AT THE TIP OF THE SCOPE EN-580T CEASED TO INFLATE DURING ILEAL INSERTION. THE BALLOON CONTROLLER PB-20 WAS REMOVED, AND A 10 ML SYRINGE WAS CONNECTED TO TRY TO DEFLATE THE BALLOON. THE BALLOON DID NOT DEFLATE, BUT WAS ABLE TO INFLATE. IMMEDIATELY AFTER INFLATING, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN, AND A LACERATION OF THE SMALL INTESTINAL MUCOSA AND SIGNIFICANT BLEEDING WERE OBSERVED. CONSERVATIVE TREATMENT BY BLOOD TRANSFUSION WAS PERFORMED, BUT THE PATIENT GOT INTO SHOCK. ANGIOGRAPHY WAS PERFORMED WHICH IDENTIFIED THE BLEEDING POINT ARTERY, SO HEMOSTASIS WAS PERFORMED BY COILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70135 FUJIFILM BALLOON BS-4 ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION BS-4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention