BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 1911462 · Received December 1, 2010

    Report

    Report Number
    3005992282-2010-00382
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PUNCTURED TUBING. THE BAND/BALLOON WITH 21CM OF CATHETER, THE INJECTION PORT WITH THE LOCKING CONNECTOR AND 8CM OF CATHETER, TWO (2) TUBING STRAIN RELIEF AND A GREEN SUTURE ON THE BAND WERE RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THREE (3) FOLD LINES WERE PRESENT ON THE BALLOON. NO TEARS OR CRACKS WERE OBSERVED ON THE BALLOON AND TUBING. IT WAS NOTED THAT THE BUCKLE WAS TORN ON ONE SIDE, TEAR MOST LIKELY PERFORMED DURING THE EXPLANTATION. DURING THE VISUAL INSPECTION ON THE INJECTION PORT, IT WAS OBSERVED THAT TWO (2) PUNCTURES WERE PRESENT ON THE TUBING. A LEAK TEST WAS PERFORMED ON THE BALLOON WITH A SUCCESSFUL RESULT. NO LEAK WAS FOUND ON THE BALLOON AND TUBING ASSOCIATED WITH THIS BALLOON. A LEAK TEST WAS PERFORMED ON THE INJECTION PORT WITH LOCKING CONNECTOR AND 8CM OF CATHETER WITH AN UNSUCCESSFUL RESULT. A LEAK WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED WITH A LEAK NEAR BAND ON TUBING POST IMPLANT A SWEDISH ADJUSTABLE BAND. THIS WAS CONFIRMED THROUGH DIAGNOSTIC TESTS. THE BAND WAS REPLACED. THE PATIENT WAS DISCHARGED HOME WITH NO PATIENT COMPLICATIONS. FACILITY IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1