BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIAID BGE DEVICE

    MDR report key: 2655814 · Received July 19, 2009

    Report

    Report Number
    3005261802-2009-00001
    Event Type
    Injury
    Date Received
    July 19, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 19, 2009
    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. HEINE ET AL DESCRIBES EXPERIENCE IN THE FIRST 275 PTS EXAMINED AND TREATED WITH THE DBE, SEVER COMPLICATIONS WERE RECOGNIZED IN (B)(4) CASES ((B)(4)), ALL INVOLVING PANCREATITIS. JARBANDHAN ET AL INDICATE THAT THE PATHOGENESIS OF POST-DBE PANCREATITIS IS NOT KNOWN. SEVERAL MECHANISMS COULD BE RESPONSIBLE FOR THE DEVELOPMENT 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 LO ET AL, 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. ALSO, IN THE USER¿S MANUAL, ONE OF THE POSSIBLE COMPLICATIONS MENTIONED IS PANCREATITIS. IN ADDITION, ALL OF SMART¿S DEVICES GO THROUGH FINAL INSPECTION FOLLOWING MFG PROCESS. NO DEVICE FAILURE OCCURRED. HEINE ET AL, DBE: INDICATIONS, DIAGNOSTIC YIELD, AND COMPLICATIONS IN A SERIES OF 275 PTS WITH SUSPECTED SMALL-BOWEL DISEASE, ENDOSCOPY, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SMART MEDICAL SYSTEM (B)(4) BY THE (B)(4) DISTRIBUTOR REGARDING A CASE OF PANCREATITIS FOLLOWING A BGE PROCEDURE. ACCORDING TO THE DISTRIBUTOR REPORT, THE PT WAS HOSPITALIZED DUE TO A CONDITION NOT RELATED TO PANCREATITIS, THE HOSPITALIZATION WAS PROLONGED DUE TO THE PANCREATITIS EVENT. THE PT WAS DISCHARGED FROM THE HOSPITAL AND IS IN GOOD HEALTH. UNTIL THE DAY OF THIS REPORT, ADD¿L DETAILS REGARDING THE PANCREATITIS EVENT WERE NOT RECEIVED FROM THE PHYSICIAN ALTHOUGH AN INVESTIGATION IS STILL ON GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIAID BGE DEVICE NAVIAID BGE DEVICE FDA SMART MEDICAL SYSTEMS LTD. 4.5 DISPOSABLE21B00074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization