BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TTP J-TUBE

    MDR report key: 836285 · Received April 6, 2007

    Report

    Report Number
    6000048-2007-00126
    Event Type
    Injury
    Date Received
    April 6, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FPD
    PMA / PMN Number
    k971906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE RETURNED REVEALED THAT THERE WAS RESIDUE ON THE DEVICE INDICATING USE, THE TUBE HAD DETACHED FROM THE FEEDING PORT ADAPTOR, AND THE TUBE HAD A HOLE. A FUNCTIONAL EVALUATION HAD DETERMINED THAT ONLY THE FEEDING PORT CAP COULD BE OPENED; THE MEDICATION AND SUCTION PORT CAPS COULD BE OPENED; THE MEDICATION AND SUCTION PORT CAPS COULD NOT BE OPENED. SINCE NO LOT NUMBER WAS PROVIDED, A SHIP HISTORY WAS CONDUCTED TO FIND THE LAST THREE LOT NUMBERS SENT TO THE CUSTOMER: 8782319, 8902005, AND 8851862. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THE THREE LOTS. THE FEBRUARY 2007 15-MONTH TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 12, 2007, THAT APPROXIMATELY FOURTEEN WEEKS AFTER THE PLACEMENT OF A TTP J-TUBE IN 2006, THE TUBE "DETACHED FROM THE ADAPTOR BASE AND REMAINED INSIDE (THE PATIENT'S) STOMACH". THE PHYSICIAN REMOVED THE DEVICE ENDOSCOPICALLY AND PLACED ANOTHER SAME DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TTP J-TUBE FPD FPD BOSTON SCIENTIFIC M00566420 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention