BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1170165 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04476
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 11, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS RETURNED TO THE FACILITY. THE EVALUATION OF THE RETURNED DEVICE IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), THE HYDRATOME TIP CRACKED AS THE PHYSICIAN WAS PUTTING THE HYDRATOME THROUGH THE SCOPE. THE CASE WAS COMPLETED WITH A DIFFERENT TOME. THE PATIENT'S CONDITION IS REPORTED AS "FINE". THIS IS THE FIRST DEVICE OF THREE THAT FAILED IN THIS EVENT. MDR REFERENCE NUMBERS: 3005099803-2008-04497, 3005099803-2008-04498.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11800121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK