BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1211090 · Received October 24, 2008

    Report

    Report Number
    3005099803-2008-05488
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIFTH OF FIVE DEVICES REPORTED FOR THE EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A DISTAL BILE DUCT PERFORATION WAS OBSERVED AFTER A PROCEDURE PERFORMED ON APPROX TWO AND A HALF MONTHS EARLIER, USING AN AUTOTOME RX SPHINCTEROTOME DEVICE. THE PT WAS ADMITTED TO THE HOSPITAL AND LATER RELEASED; THE PT'S CONDITION WAS REPORTED TO BE "FINE". ACCORDING TO THE COMPLAINANT, THE RELATIONSHIP BETWEEN THE DUCT PERFORATION AND THE AUTOTOME SPHINCTEROTOME DEVICE IS UNK. REFER TO MFR REPORTS # 3005099803-2008-05484, 3005099803-2008-05485, 3005099803-2008-05486, AND 3005099803-2008-05489 FOR THE OTHER FOUR DEVICES USED IN THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O