BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 806809 · Received January 9, 2007

    Report

    Report Number
    6000089-2007-00049
    Event Type
    Malfunction
    Date Received
    January 9, 2007
    Date of Event
    December 6, 2006
    Report Date
    December 11, 2006
    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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MFG RECORDS FOR TOP ASSEMBLY BATCH # 9030736 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. ALL RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. WE WILL HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PCI PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS IN THE HIGHLY CALCIFIED, 90% STENOSED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE MAVERICK2 MONORAIL BALLOON RUPTURED AT 12 ATMS ON THE SECOND INFLATION. THE INITIAL INFLATION WAS TO 10 ATMS. THE PROCEDURE WAS COMPLETED WITH A QUANTUM MAVERICK BALLOON AND ANOTHER MFR'S STENT. 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 CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOU LOX BOSTON SCIENTIFIC MAVERICK2 12/2.0 0009030736

    Patients

    Seq Age Sex Outcome Treatment
    1 * STENT: CYPHER