BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE SINGLE-USE WIREGUIDED ESOPHAGEAL/PYLORIC BALLOON

    MDR report key: 2954158 · Received January 31, 2013

    Report

    Report Number
    2954158
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO ADVANCE THE FIRST BALLOON WITHOUT SUCCESS. A NEW SCOPE WAS USED TO RULE OUT A MALFUNCTION WITH THE SCOPE. A SECOND BALLOON WAS ADVANCED WITH SOME RESISTANCE. THE PROCEDURE WAS DONE AND THE BALLOON WAS INFLATED. HOWEVER, WHEN THE PHYSICIAN REMOVED THE SCOPE, THE BALLOON WAS DIFFICULT TO REMOVE AND THE HANDLE OF THE DEVICE BROKE. THE TECH WAS ABLE TO EVENTUALLY REMOVE THE BALLOON.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ESOPHAGOGASTRODUODENOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42011 CRE SINGLE-USE WIREGUIDED ESOPHAGEAL/PYLORIC BALLOON DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC REF 5847 15504080
    42012 * * --- BOSTON SCIENTIFIC 5850 15555319

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR SCOPE AND BALLOONS BEING USED