BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS

    MDR report key: 1328458 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01722
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Report Date
    October 12, 2005
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Product Code
    KNT
    PMA / PMN Number
    K971757
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE BALLOON HAS A LARGE TEAR IN IT, RENDERING THE DEVICE NON-FUNCTIONAL. NO CONCLUSION COULD BE DRAWN REGARDING THE ROOT CAUSE OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS DEVICE WAS PLACED IN AN ENTERAL FEEDING REPLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, ONE DAY AFTER DEVICE PLACEMENT, THE BALLOON RUPTURED. ANOTHER DEVICE WAS USED TO REPLACE THIS DEVICE (UNKNOWN DEVICE). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE LOW PROFILE BALLOON REPLACEMENTS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGIES M00563680

    Patients

    Seq Age Sex Outcome Treatment
    1