BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1193272 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05099
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ESOPHAGEAL DILATION PROCEDURE, THE DEVICE APPEARED BENT. A CRE 18-20MM 8CM F/G BALLOON HAD BEEN SELECTED TO TREAT AN UNSPECIFIED ESOPHAGEAL STRICTURE. WHEN THE DEVICE PACKAGING WAS OPENED, IT WAS NOTICED THAT THERE APPEARED TO BE A "BEND" ON THE DEVICE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558380 11819316

    Patients

    Seq Age Sex Outcome Treatment
    1