BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 775758 · Received November 2, 2006

    Report

    Report Number
    6000123-2006-00081
    Event Type
    Injury
    Date Received
    November 2, 2006
    Date of Event
    October 23, 2006
    Report Date
    October 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE THE RELATIONSHIP THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IN 2006, IT WAS REPORTED TO BSC THAT DURING A THERAPEUTIC ERCP (FEMALE PATIENT, AGE UNKNOWN) THE TIP DETACHED. THE CUSTOMER REPORTED THE TIP WILL NOT BE RETRIEVED, BUT WILL PASS BY NORMAL PERISTALSIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE CUSTOMER REPORTED, "ANTIBIOTIC THERAPY WAS PROVIDED TO THE PATIENT TO AVOID ANY INFECTION...". THERE WAS NO REPORTED COMPLICATION OR ILL EFFECT SUSTAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR GUIDEWIRE DQX BOSTON SCIENTIFIC M0055658010 6711819

    Patients

    Seq Age Sex Outcome Treatment
    1 *