BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 2153307 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02086
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE INITIAL CANNULATING ORIENTATION OF THE DEVICE WAS INCORRECT. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER COMPLAINS FOR THE REPORTED LOT NUMBER. THE (B)(6) 2008, 15-MONTH JAGTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008 THAT A JAGTOME RX DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2008. ACCORDING TO THE PHYSICIAN, "THE DEVICE ORIENTED TOO MUCH TO THE RIGHT." THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX SPHINCTEROTOME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00573080 11509462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK