BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1101690 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02219
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, A BALLOON PUNCTURE OCCURRED. THORACOTOMY WAS PERFORMED FOR AORTIC VALVE REPLACEMENT, HOWEVER, VALVE REPLACEMENT WAS NOT POSSIBLE DUE TO SEVERE CALCIFICATION. IN ORDER TO CLOSE THE PROCEDURE, THE EQUALIZER BALLOON CATHETER WAS USED TO OCCLUDE THE BLOOD FLOW OF THE ASCENDING AORTA. WHILE STITCHING THE BLOOD VESSEL, THE NEEDLE PUNCTURED THE EQUALIZER BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, "THE PHYSICIAN NOTICED A PIECE OF THE BALLOON MATERIAL WAS MISSING AND SUSPECTED THAT IT COULD HAVE REMAINED IN THE BODY." THE PT'S CONDITION 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 17-111 11574567

    Patients

    Seq Age Sex Outcome Treatment
    1 Other