BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK BALLOON DILATION CATHETER

    MDR report key: 2013237 · Received March 10, 2011

    Report

    Report Number
    2134265-2011-00582
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    July 13, 2010
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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. NO LESION DETAILS ARE AVAILABLE. THE 2.5 X 20MM MAVERICK OVER-THE-WIRE BALLOON CATHETER RUPTUED DURING AN INFLATION THAT WAS WITHIN SPECIFICATION. A DISSECTION OF THE ARTERY OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    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 H7492062020250

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other