BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1476276 · Received June 19, 2009

    Report

    Report Number
    2134265-2009-02907
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    May 25, 2009
    Report Date
    May 25, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) # P860019/S208.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION LOCATION AND CHARACTERISTICS WERE UNK. WHEN THE LESION WAS DILATED WITH THE 2.0X15MM APEX BALLOON SEVERAL TIMES, IT WAS RUPTURED AT UNK ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS. THE PT STATUS WAS REPORTED AS"FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 2.0X15MM 12412368

    Patients

    Seq Age Sex Outcome Treatment
    1