BEUDAMED
    FDA Adverse Event Summary report: N

    TRUE DILATATION

    MDR report key: 3691920 · Received March 12, 2014

    Report

    Report Number
    3691920
    Date Received
    March 12, 2014
    Date of Event
    November 20, 2013
    Report Date
    January 13, 2014
    Manufacturer
    LOMA VISTA MEDICAL
    Product Code
    OZT
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LOMA VISTA BARD BALLOON TRUE DILATATION BALLOON COULD NOT BE REMOVED THROUGH THE 14F SHEATH. THE BALLOON DID NOT FOLD PROPERLY AFTER DEFLATION. THE SHEATH AND BALLOON WERE BOTH REMOVED TOGETHER WHILE MAINTAINING WIRE ACCESS. ANOTHER 14F SHEATH WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149249 TRUE DILATATION BALLOON AORTIC VALVULOPLASTY OZT LOMA VISTA MEDICAL * PLN 01298

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR