BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23MM X 4CM X 130CM EDWARDS BALLOON CATHETER

    MDR report key: 6995835 · Received November 2, 2017

    Report

    Report Number
    6995835
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 23, 2015
    Report Date
    October 25, 2017
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    OZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF THE EDWARDS TAVR VALVE THE INFLATION BALLOON RUPTURED AND VALVE WAS UNABLE TO BE DEPLOYED - ALTHOUGH IT DID EXPAND ENOUGH TO PREVENT THE VALVE TO BE RETRACTED BACK IN THE DELIVERY SHEATH - THE VALVE WAS ULTIMATELY REMOVED FROM THE ACCESS SITE OF THE LT SUBCLAVIAN ARTERY WITH A CUT DOWN AND PATCH GRAFTING NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777603 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER BALLOON AORTIC VALVULOPLASTY OZT EDWARDS LIFESCIENCES LLC 9350BC23

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR