BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1161560 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04575
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE THE BALLOON "BUSTED". THE TARGET STRICTURE WAS IN THE ESOPHAGUS. A CRE 15-18MM 8CM F/G BALLOON DILATION CATHETER HAD BEEN SELECTED TO TREAT THE TARGET STRICTURE. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE BALLOON "BUSTED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558370 11639205

    Patients

    Seq Age Sex Outcome Treatment
    1