BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1220276 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04177
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    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 CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE 2.0X12MM APEX BALLOON CATHETER TO THE LESION AND INFLATED IT TO 6ATMS FOR TEN SECONDS, AND THE BALLOON RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.0X12MM APEX BALLOON CATHETER BALLOON. PT STATUS IS REPORTED AS "GOOD". THIS DEVICE IS ONLY OUS APPROVED, BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.0X12 MM 11196887

    Patients

    Seq Age Sex Outcome Treatment
    1