BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 2911585 · Received April 11, 2007

    Report

    Report Number
    6000093-2007-00757
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 14, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED CIRCUMFLEX ARTERY. THE PHYSICIAN INITIALLY ATTEMPTED TO DILATE THE LESION WITH A 2.75X15MM QUANTUM MAVERICK MONORAIL BALLOON. THE BALLOON WAS INFLATED TO 7 ATMS BUT RUPTURED. THE PHYSICIAN THEN USED A 2.75X15MM MAVERICK2 MONORAIL BALLOON WHICH RUPTURED AT 10 ATMS. A 2.5X12MM MAVERICK2 MONORAIL BALLOON WAS THEN USED. THE BALLOON WAS INFLATED TWICE, BUT BURST AT 12 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. THERE WERE NO REPORTED PATIENT COMPLICATIONS. PATIENT STATUS LISTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 12/2.5 9375489

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR