BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 1170168 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04511
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN DUODENUM, A JAGTOME RX SPHINCTEROTOME WAS USED FOR SPHINCTEROTOMY OF THE PAPILLA. THE INTRODUCTION OF THE CATHETER WAS NORMAL (I.E. DURING ANGLING THE CATHETER, THE WIRE WAS AT THE UPPER SIDE). THEN THE PHYSICIAN PULLED THE CUTTING WIRE AND NOTICED THAT THE WIRE WAS AT THE UNDER SIDE OF THE ANGLE. THE PHYSICIAN REMOVED THE CATHETER AND HE USED A NEW ONE, AND HAD THE SAME PROBLEM. THEN THEY USED A SPHINCTEROTOME FROM ANOTHER MANUFACTURER AND THIS DEVICE WORKED OKAY. THE PATIENT'S CONDITION IS REPORTED AS OKAY. THIS IS ONE OF THE TWO DEVICES THAT FAILED IN THIS EVENT. MDR REFERENCE NUMBER: 3005099803-2008-04507.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00573550 0011699844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK