BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR ERCP CANNULA

    MDR report key: 1160031 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04517
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION 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 UNKNOWN PROCEDURE PERFORMED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, THE TIP OF THE CANNULA WAS BENT, PRECLUDING IT'S ABILITY TO CANNULATE THE CBD (COMMON BILE DUCT). THE PROCEDURE WAS COMPLETED WITH ANOTHER CONTOUR ERCP CANNULA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK