BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1202851 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05300
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DUODENAL STENT PLACEMENT PROCEDURE, THE HANDLE OF THE DEVICE FRACTURED. THE INDICATION FOR THE PROCEDURE WAS FOR PALLIATION OF ADVANCED DUODENAL CANCER AT THE DUODENAL BULB. THE PHYSICIAN BEGAN TO DEPLOY THE WALLFLEX 27/22X12 230CM ENTERAL DUODENAL STENT BY IMMOBILIZING THE HUB HANDLE AND SLIDING THE EXTERIOR TUBE HANDLE BACK TOWARDS THE HUB HANDLE. WHILE THE STENT WAS BEING DEPLOYED, THE EXTERIOR TUBE HANDLE BECAME DETACHED FROM THE EXTERIOR TUBE. THE STENT WAS UNABLE TO BE RELEASED AND THE DEVICE WAS REMOVED. BECAUSE ANOTHER WALLFLEX DUODENAL STENT WAS UNAVAILABLE, THE PROCEDURE COULD NOT BE COMPLETED AND THE PROCEDURE WAS RESCHEDULED FOR 5 DAYS LATER. NO PT COMPLICATIONS OCCURRED. PT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC 6503 0011882869

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other