BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1030703 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01109
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    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 COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON RUPTURED. THE LESION BEING TREATED WAS 90% STENOSED WITH CALCIFICATION IN AN EXTREMELY TORTUOUS LEFT CIRCUMFLEX OBTUSE MARGINAL BRANCH. DURING PREDILATATION, ON THE FIRST INFLATION, THE 2.0X15MM MAVERICK2 MONORAIL BALLOON WAS INFLATED FOR 20 SECONDS AND RUPTURED AT 14 ATMOSPHERES. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. THE BALLOON WAS REMOVED INTACT. COMPLETED PROCEDURE WITH A DIFFERENT DEVICE. THE PT STATUS IS 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 15 / 2.0 0011320785

    Patients

    Seq Age Sex Outcome Treatment
    1 GW: RINATO| GC: BRIGHT TIP 6F