BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2232880 · Received September 2, 2011

    Report

    Report Number
    3005992282-2011-00193
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 10, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TEAR. THE BAND/BALLOON WITH 41.5CM OF CATHETER AND A PIECE OF THE BAND (DIAMOND INDICATOR) WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DIAMOND INDICATOR AND SUTURE WERE RETURNED CUT, PROBABLY OCCURRED DURING THE EXPLANT. IT WAS ALSO OBSERVED THAT BAND/BALLOON WAS COVERED WITH BLACK STAINS. UPON MICROSCOPIC EVALUATION, IT WAS OBSERVED THAT THE TWO (2) TEARS WERE ON THE BALLOON. THE FIRST TEAR IS 8.3MM IN LENGTH AND IS LOCALIZED ON CATHETER CONNECTION; THE SECOND TEAR IS 5.63MM AND LOCALIZED ON BALLOON CLOSED END. THESE TEARS WERE PROBABLY PERFORMED DURING THE EXPLANT OF THE BAND. THE ORIGIN OF THE LEAK COULD NOT BE LOCATED DUE THE CONDITION IN WHICH THE DEVICE WAS RETURNED. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) WERE REVIEWED WITH RESPECT TO BALLOON LEAKAGE AND IT IS NOTED THAT BALLOON LEAKAGE IS LISTED WITHIN THE PRODUCT'S IFU AS A RECOGNIZED EVENT ASSOCIATED WITH THE SWEDISH ADJUSTABLE GASTRIC BAND EVENTS. IT WAS ALSO NOTED THAT FLUID LOSS FROM THE BALLOON CAN OCCUR AT ANY TIME, FOR A NUMBER OF REASONS, INCLUDING GENERAL DETERIORATION OF THE BALLOON OVER TIME. THE FINAL PACKAGING LOT WAS NOT COMMUNICATED; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. MANUFACTURING PRACTICES WERE REVIEWED AND IT WAS NOTED THAT ALL DEVICES ARE 100% LEAK TESTED PRIOR TO LOT RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND THERE WAS A LEAK IN THE BALLOON. THE BAND WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1