BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1911665 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05265
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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 RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION AND THE BALLOON WAS INFLATED TO 6 ATMS. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATMS. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815150 12962908

    Patients

    Seq Age Sex Outcome Treatment
    1