BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 1230751 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05541
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN RECEIVED. THE DEVICE EVAL HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. THAT A JAGTOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN EXPERIENCED DIFFICULTY TO GET THE DEVICE TO EXIT THE DISTAL END OF THE ENDOSCOPE. IT WAS ALSO REPORTED THAT "THE BLUE TIP OF THE TOME APPEARED CROOKED AND BENT." THE DEVICE WAS REMOVED, AND REPLACED WITH ANOTHER JAGTOME RX SPHINCTEROTOME DEVICE, WHICH WAS USED TO COMPLETED THE REPORTEDLY "UNEVENTFUL CASE". THERE WERE NO PT COMPLICATIONS 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 M00573540 11701409

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK