BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE MAX 20 HIGH PRESSURE BALLOON DILATATION CATHETER

    MDR report key: 3212743 · Received July 2, 2013

    Report

    Report Number
    MW5030785
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER FAILED TO DEPLOY DURING SURGICAL PROCEDURE. THE PT DID DIE AS A RESULT OF COMPLICATIONS THAT OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THEY PHYSICIAN DID NOT FEEL THAT THE DEATH WAS RELATED TO THE USE OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300563 BLUE MAX 20 HIGH PRESSURE BALLOON DILATATION CATHETER BALLOON CATHETER LIT BOSTON SCIENTIFIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other