BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1903809 · Received November 20, 2010

    Report

    Report Number
    3005992282-2010-00372
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    September 15, 2009
    Report Date
    November 5, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND/BALLOON WITH 2.5CM OF CATHETER, THE INJECTION PORT, ONE PIECE OF CATHETER AND THE LOCKING CONNECTOR WERE RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT 3 FOLDLINES WERE OBSERVED ON THE BALLOON, THESE FOLDLINES WERE LOCALIZED NEAR THE CATHETER CONNECTION, PALE YELLOW STAINING AND SMALL DARK BROWN SPOTS ON BAND, BALLOON AND BUCKLE. THE BUCKLE WAS CUT AND TUBING STRAIN RELIEF WAS NOT RETURNED FOR EVALUATION. THE EVENT CANNOT BE CONFIRMED, DEVICE ANALYSIS CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE. BAND SLIPPAGE IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GASTRIC DILATATION WAS OBSERVED AND TO RESOLVE WITH THE REMOVAL OF THE (B)(4) ADJUSTABLE GASTRIC BAND. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ADDITIONAL FOLLOW UP IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention