BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1181630 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02842
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 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

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. ON THE FIRST INFLATION A 1.5X15MM MAVERICK2 MONORAIL BALLOON CATHETER WAS INFLATED TO 12 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT STATUS IS "NO PROBLEM" WITH NO COMPLICATIONS REPORTED.

    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 15/1.5 0008562721

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR XTREME