BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1030615 · Received April 16, 2008

    Report

    Report Number
    2134265-2008-01105
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #'S: 2134265-2008-01104 AND 2134265-2008-01105. IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, THREE BALLOON RUPTURES OCCURRED. DURING A CHORONOGRAPHY STUDY, IT WAS DISCOVERED THAT THE PT HAD MULTIVESSEL LESIONS IN THE DESCENDING ARTERY AND THE PHYSICIAN DECIDED TO PERFORM THE STENTING PROCEDURE. AFTER GUIDE WIRE PLACEMENT, THREE MAVERICK2 MONORAIL BALLOON CATHETERS WERE USED FOR DILATION IN THE FOLLOWING ORDER: 15MM X 2.0MM, 12MM X 2.0MM AND 20MM X 3.0MM. ALL THREE BALLOONS RUPTURED. THE FINAL BALLOON (20MM X 3.0MM) COMPLETED THE DILATION. THE TOTAL NUMBER OF INFLATIONS AND TO WHAT ATMS FOR EACH BALLOON IS UNK. ANOTHER MFR'S STENT WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "STABLE". ADD'L INFO HAS BEEN REQUESTED REGARDING THIS EVENT, BUT HAS NOT BEEN RECEIVED.

    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 / 2.0 11104703

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR