BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR ERCP CANNULA

    MDR report key: 1161363 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04535
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODD
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A LEAK WAS DISCOVERED IN THE CATHETER BELOW THE HUB. THE CASE WAS COMPLETED WITH ANOTHER CONTOUR ERCP CANNULA DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR ERCP CANNULA ODD BOSTON SCIENTIFIC CORPORATION M00530860 0000606529

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK