BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1170690 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04586
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (MISORIENTATION) - 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 CORP IN 2008, THAT AN AUTOTOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, ONCE THE DEVICE WAS PASSED THROUGH THE ENDOSCOPE, THE AUTOTOME RX SPHINCTEROTOME "WAS DISORIENTATED WHEN IT EXITED THE [ENDO] SCOPE. CANNULATING THE AMPULLA WAS VERY DIFFICULT." THE CASE WAS COMPLETED WITH A SECOND AUTOTOME RX SPHINCTEROTOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 11609315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK