BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK BALLOON DILATION CATHETER

    MDR report key: 2093480 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01985
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE A BALLOON RUPTURE OCCURRED. INTRAVASCULAR ULTRA SOUND WAS PERFORMED. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. THE 5.5/120/153 MAVERICK XL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION WHEN THE BALLOON RUPTURED AT 14 ATM ON THE THIRD INFLATION. THE FIRST AND SECOND INFLATIONS WERE ALSO TO 14 ATM EACH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK BALLOON DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493790955200 13001501

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: BRITE TIP JR4| GUIDE WIRE: TRAVERSE