BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 2153394 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02014
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (MISORIENTED). THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS FOR THIS LOT. (B)(4).

    Description of Event or Problem · 1

    A JAGTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN AN (B)(6), FEMALE, PT, ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ORIENTATION OF THE DEVICE WAS WRONG AND THE PHYSICIAN COULD NOT CANNULATE THE DUCT. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX SPHINCTEROTOME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PT'S CONDITION WAS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME NONE KNS BOSTON SCIENTIFIC CORPORATION M00583040 11441333

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR