BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BALLOON COOK HERCULES 3 STAGE

    MDR report key: 9029108 · Received September 12, 2019

    Report

    Report Number
    MW5089773
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 10, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN MPU ROOM 7 FOR EGO PROCEDURE. WE HAVE SWITCHED OUR PRODUCT TO COOK FROM BOSTON SCIENTIFIC. WE USED THE COOK BALLOON TODAY, THE 18-20MM THROUGH SCOPE DILATOR (HURRICANE IS THE SAME I BELIEVE). INFLATED 18MM IN STRICTURE AND HELD FOR 60 SEC THEN WENT UP TO 19MM AND THEN BALLOON RUPTURED WHEN WE WENT UP TO 20MM MARK AFTER ABOUT 10 SEC. HAD TO REPEAT THE DILATION, CUT THE BALLOON AND REDO. THIS ADDED EXTRA TIME AS WELL AS EXTRA COST WHEN GOING THROUGH 2 BALLOONS INSTEAD OF 1. DURING PROCEDURE BALLOON WAS INFLATED AS DIRECTED BY PHYSICIAN. STAFF APPLIED NEGATIVE PRESSURE TO BALLOON AS INSTRUCTED, INFLATED TO DESIRED AND RECOMMENDED VOLUME. BALLOON WAS INITIATED TO 18 (4 PRESSURE) 19 (5 PRESSURE) 20 (6 PRESSURE). INFLATION WAS WITH THE BIG 60 DEVICE AND WE INFLATED TO 6 ATMOSPHERIC PRESSURE. NO TENSION WAS NOTED AND PHYSICIAN STATED BALLOON WAS NOT INFLATED. UPON REMOVAL, IT WAS NOTED BALLOON WAS INFLATED AND POSSIBLE BURST DURING PROCEDURE. NOTHING WAS RETAINED BY PT. NO ADD'L PROCEDURES NEEDED AND PROCEDURE CONTINUED AFTER REMOVAL. BALLOON COOK HERCULES 3 STAGE BALLOON, HBD-18-19-20 MFT #G31927, LOT # W4221939. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797580 COOK BALLOON COOK HERCULES 3 STAGE DILATOR, ESOPHAGEAL KCF COOK ENDOSCOPY HBD-18-19-20 W4221939

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR