BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR ERCP CANNULA

    MDR report key: 1133451 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03800
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A CONTOUR ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON THIRTEEN DAYS EARLIER. ACCORDING TO THE COMPLAINT, THE DEVICE, DURING THE PROCEDURE, THE TIP OF THE CATHETER WAS BENT ONCE IT CAME OUT OF THE (ENDO) SCOPE. THE PROCEDURE WAS COMPLETED WITH A SECOND CONTOUR ERCP CANNULA DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR ERCP CANNULA FGE BOSTON SCIENTIFIC CORPORATION M00530880 0000606534

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK