BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1230727 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05494
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) OF THE COMMON BILE DUCT; THE HYDROTOME WAS "NOT BOWING ENOUGH". THE PHYSICIAN MADE TWO ADDITIONAL ATTEMPTS WITH TWO OTHER SIMILAR DEVICES AND EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PT WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE. THIS REPORT IS BEING FILED FOR ONE OF THREE DEVICES THAT DID NOT BOW CORRECTLY, REFER TO MFR# 3005099803-2008-05495 AND 3005099803-2008-05496 FOR THE REPORT ON THE OTHER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 119723383

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK