BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG HINI

    MDR report key: 790319 · Received December 4, 2006

    Report

    Report Number
    6000123-2006-00096
    Event Type
    Injury
    Date Received
    December 4, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WERE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    ON NOVEMBER 27, 2006, IT WAS REPORTED TO BSC THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (FEMALE PATIENT, AGE UNKNOWN) THE "HYDROPHILIC COATING STRIPPED OFF INSIDE THE PATIENT." THE CUSTOMER REPORTED THEY "DECIDED NOT TO RETRIEVE" THE COATING. THE PATIENT IS "IN HOSPITAL FOR OBSERVATION, HAVING AN X-RAY TO SEE IF COATING HAS PAST (PASSED)." THE PROCEDURE WAS COMPLETED WITH ANOTHER BSC JAG HINI GUIDEWIRE. THE CUSTOMER REPORTED THERE WAS NO PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG HINI EZB EZB BOSTON SCIENTIFIC M00556461 8964116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN