BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE BALLOON

    MDR report key: 1182363 · Received September 18, 2008

    Report

    Report Number
    1182363
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDERGOING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) AND MD UNABLE TO ADVANCE ERCP THROUGH DUODENAL BULB. EGD SCOPE INSERTED AND DUODENAL BULB STRICTURE NOTED. DILATED WITH CRE ESO/PLY/COL WIRE GUIDED BALLOON, 30 FR AND A NEW 45 FR BALLOON FOR UNDER FLUOROSCOPY. EGD SCOPE INTO QUESTIONABLE AREA. PROCEDURE STOPPED AND X-RAYS DONE. SHOWED PNEUMATOSIS, RETROPERITONEAL AIR AND LIKELY FREE INTRAPERITONEAL AIR. POSSIBLE BOWEL PERFORATION. X-RAY DONE NEXT DAY, IT SHOWED MILD DECREASE IN AMOUNT OF FREE AIR SINCE PRIOR EXAM. GB SURGERY THAT WAS SCHEDULED FOR DAY OF X-RAY WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON WIREGUIDED, BALLOON, DILATOR FDS BOSTON SCIENTIFIC 5849 8443439/8959153

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R