BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIAID BGE DEVICE

    MDR report key: 2667216 · Received September 21, 2008

    Report

    Report Number
    3005261802-2008-00001
    Event Type
    Injury
    Date Received
    September 21, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 21, 2008
    Manufacturer
    SMART MEDICAL SYSTEMS LTD.
    Product Code
    FDA
    PMA / PMN Number
    K060923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PANCREATITIS IS A WELL KNOWN COMPLICATION IN DOUBLE BALLOON ENTEROSCOPY (DBE) WHICH IS A SIMILAR PROCEDURE. (B)(6) DESCRIBES EXPERIENCE IN THE FIRST 275 PTS EXAMINED AND TREATED WITH THE DBE, SEVERE COMPLICATIONS WERE RECOGNIZED IN THREE CASES (1%), ALL INVOLVING PANCREATITIS. (B)(6) INDICATE THAT THE PATHOGENESIS OF POST-DBE PANCREATITIS IS NOT KNOWN. SEVERAL MECHANISMS COULD BE RESPONSIBLE FOR THE DEPLOYMENT OF HYPERAMYLASEMIA OR PANCREATITIS: REPETITIVE MECHANICAL STRAIN ON THE PANCREAS BY INSERTING ENDOSCOPE/OVERTUBE, BY INFLATED BALLOONS OR STRETCHING MOVEMENTS OR DUODENAL HYPERTENSION DUE TO AIR TRAPPING BETWEEN BALLOON AND PYLORUS. ALTHOUGH POST-DBE PANCREATITIS IS RELATIVELY UNCOMMON IT IS THE MOST IMPORTANT COMPLICATION OF ANTEGRADE DBE. ACCORDING TO (B)(6), SIMILAR TO DBE, BOTH SINGLE BALLOON ENTEROSCOPE AND SPIRAL SMALL BOWEL OVERTUBE USE AN OVERTUBE TO SHORTEN THE SMALL INTESTINE AND THEREFORE DUODENAL INJURY MAY OCCUR. SMART MEDICAL SYSTEMS INDICATE BOTH IN THE USER'S MANUAL AND IN THE TRAINING SESSIONS THAT THE OPERATION OF THE BGE DEVICE WILL BEGIN ONLY ONCE THE SMALL INTESTINE IS REACHED AFTER THE 2ND PART OF THE DUODENUM, TO MINIMIZE PANCREATITIS RISK. IN ADDITION, ALL OF SMART'S DEVICES GO THROUGH FINAL INSPECTION FOLLOWING MANUFACTURING PROCESS. NO DEVICE FAILURE OCCURRED. APPROX 200 BGE PROCEDURES WERE PERFORMED SO FAR, THIS WAS THE FIRST REPORT OF PANCREATITIS. HEINE ET AL, DBE: INDICATIONS, DIAGNOSTIC YIELD, AND COMPLICATIONS IN A SERIES OF 275 PTS WITH SUSPECTED SMALL-BOWEL DISEASE, ENDOSCOPY, 2006 JAN; 38(1): 42-8. SOERESH ET AL, DBE ASSOCIATED PANCREATITIS: A DESCRIPTION OF 6 CASES. SIMON ET AL, PANCREATITIS ASSOCIATED WITH DBE: HOW COMMON IS IT?, GIE (66) 6: 2007, P. 1139-41.

    Description of Event or Problem · 1

    BEGINNING OF (B)(6) (EXACT DATE UNK): (B)(6) FEMALE WAS HOSPITALIZED DUE TO CHRONIC UPPER ABDOMINAL PAIN. (B)(6) 2008: BGE PROCEDURE WAS PERFORMED. PT CONTINUE TO COMPLAIN ABOUT ABDOMINAL PAIN. (B)(6) 2008: LABORATORY TESTS AND MRI WERE PERFORMED AND PANCREATITIS WAS DIAGNOSED. PT WAS TREATED FOR PANCREATITIS USING CONSERVATIVE THERAPY: FOOD RESTRICTION, PAIN RELIEF. (B)(6) 2008: PT DISCHARGED FROM THE HOSPITAL. (B)(6) 2008: PT ARRIVED TO THE HOSPITAL FOR FOLLOW UP TESTS, LABORATORY TESTS SHOWED A DECREASE IN AMYLAZE-LIPAZE LEVELS, PT WAS RELEASED, NO FURTHER TREATMENT WAS REQUIRED. EVENT WAS FIRST REPORTED TO SMART MEDICAL SYSTEMS LTD. ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIAID BGE DEVICE NAVIAID BGE DEVICE FDA SMART MEDICAL SYSTEMS LTD. 4.1 DISPOSABLE21A00041

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization LORAZEPAM| LEFLUNOMIDE| (ALL CHRONIC)| QUINAPRIL-HYDROCHLOROTHIAZIDE| PREDNISOLONE| OMEPRAZOLE| BUDESONIDE| TRAMADOL| DULOXETINE