BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 850648 · Received March 8, 2007

    Report

    Report Number
    6000089-2007-00348
    Event Type
    Malfunction
    Date Received
    March 8, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    p860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME EVENT AS MFR# 6000083-2007-00349. IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE IVUS CATHETER WAS NOT ABLE TO CROSS THE LESION. FOLLOWING PRE-DILATION WITH A 3.0X12MM MAVERICK2 MONORAIL BALLOON, THE LESION WAS CONFIRMED WITH IVUS IMAGING. ANOTHER MFR'S STENT WAS IMPLANTED. THE PHYSICIAN USED A KISSING BALLOON TECHNIQUE WITH THIS BALLOON AND A 2.0X12MM MAVERICK2 MONORAIL BALLOON TO POST-DILATE THE STENT. THE BALLOON RUPTURED AT 10 ATMS ON THE SECOND INFLATION. THE INITIAL INFLATION WAS TO 12 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MAVERICK2 MONORAIL BALLOON CATHETER. THERE WERE NO REPORTED PT COMPLICATIONS. PT STATUS LISTED AS "GOOD".

    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 12/3.0 0009103848

    Patients

    Seq Age Sex Outcome Treatment
    1 *