BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1180984 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02822
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE TREATMENT WAS FOR A ABDOMINAL AORTIC ANEURYSM. THE EQUALIZER BALLOON WAS BEING USED TO POST-DILATE THE STENT GRAFT. THE EQUALIZER BALLOON WAS INFLATED WITH A 20CC INFLATION SYRINGE. WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, IT WOULD NOT DEFLATE. THE PHYSICIAN CHANGED TO A 10CC SYRINGE AND WAS ABLE TO DEFLATE THE BALLOON FOR REMOVAL WITHOUT INCIDENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES, AND PATIENT STATUS WAS REPORTED AS 'STABLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC 17-109 11734881

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCLUDER GRAFT