BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFORCE BALLOON DILATATION CATHETER

    MDR report key: 1062029 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00727
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K934697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15 MONTH MAXFORCE BALLOONS TTS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC IN 2008, THAT A MAXFORCE BALLOON DILATATION CATHETER WAS USED DURING A ENDOSCOPIC ESPHAGEAL DILATATION PROCEDURE. ACCORDING TO COMPLAINANT, "DURING THE PROCEDURE, THE BALLOON BURST OPEN INSIDE THE PATIENT." REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH A SECOND MAXFORCE BALLOON DILATATION CATHETER. AFTER THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFORCE BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORPORATION M00589150 11340602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK