BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1503706 · Received September 29, 2009

    Report

    Report Number
    2134265-2009-05333
    Event Type
    Malfunction
    Date Received
    September 29, 2009
    Date of Event
    August 28, 2009
    Report Date
    August 31, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). VISUAL AND MICROSCOPIC ANALYSIS REVEALED THAT BALLOON HAD RUPTURED. THERE WAS BLOOD BOTH ON THE INSIDE AND OUTSIDE OF THE CATHETER. THE BALLOON WAS FOUND TO BE RUPTURED AND A PIECE OF THE BALLOON WAS MISSING. THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED USER ERROR AS THE BALLOON WAS INFLATED ABOVE THE RECOMMENDED VOLUME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN WAS TREATING AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL WAS MODERATELY TORTUOUS. THE EQL/27/7/2/100 BALLOON WAS USED FOR POST DILATION. THE BALLOON WAS INFLATED WITH 20MM OF LIQUID USING A 20ML SYRINGE. DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC 17-108 12617289

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: 0.035" AMPLATZ