BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 2930160 · Received January 25, 2013

    Report

    Report Number
    3005992282-2013-00008
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 4, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUNCTURED AND CUT PER VISUAL INSPECTION, IT WAS OBSERVED THAT BALLOON WAS RETURNED IN TWO PIECES MAKING ANY FURTHER TESTING DIFFICULT. TESTING OF THE CATHETER INDICATED THAT LOCATED A PUNCTURE, PROBABLY PERFORMED BY NEEDLE USE ON THE CATHETER. IT CAN TENTATIVELY BE CONCLUDED THAT LEAKAGE ON THE TUBING (CATHETER) MIGHT BE THE RESULT OF A PERFORATION OF THE TUBING BY A HUBER NEEDLE DURING BAND ADJUSTMENT. DETAILED INSTRUCTIONS ARE PROVIDED WITHIN THE INSTRUCTION FOR USE (IFU) FOR ADEQUATE TECHNIQUES FOR BAND ADJUSTMENT PROCEDURE. A 5 MM TEAR WAS IDENTIFIED ON THE BALLOON BUT LEAKAGE FROM THE BALLOON CANNOT BE CONFIRMED DUE TO THE CONDITION IN WHICH THE DEVICE WAS RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE FINAL PACKAGING LOT , AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED AND IT IS NOTED THAT ALL PRODUCTS ARE 200% LEAK TESTED PRIOR TO RELEASE, THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE REMAINS IMPLANTED. EXPLANT DATE NOT SCHEDULED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF THE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND ON (B)(6) 2010; THE PATIENT COMPLAINED THAT THERE WAS NO RESTRICTION. THE SURGEON DID A DYE STUDY AND A HOLE WAS CONFIRMED. THE ADJUSTABLE GASTRIC BAND HAS NOT BEEN REMOVED FROM THE PATIENT. THE PLAN IS TO REMOVE AND REPLACE THE CURRENT BAND. SURGERY DATE NOT YET SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35549 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZLMBBL

    Patients

    Seq Age Sex Outcome Treatment
    1