BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 889532 · Received March 14, 2007

    Report

    Report Number
    6000123-2007-00009
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Date of Event
    February 19, 2007
    Report Date
    February 19, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. ROLLING 15-MONTH COMPLAINT TREND REPORTS FOR THIS PRODUCT FAMILY, FOR ALL COMPLAINT FAILURE MODES, WERE REVIEWED; NO ADVERSE TRENDS WERE NOTED. LOT HISTORY REVIEW PERFORMED ON THE REPORTED LOT REVEALS NO ANOMALIES RELATED TO COMPLAINT. LOT MET ALL SPECIFICATIONS RELEVANT TO THE COMPLAINT UPON LOT RELEASE.

    Description of Event or Problem · 1

    IN 2007, IT WAS REPORTED TO BSC THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (MALE PATIENT) THE TIP OF THREE GUIDEWIRES "PARTIALLY FELL OFF INTO THE PATIENT." NO RETRIEVAL PROCEDURE WAS NECESSARY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH BSC GUIDEWIRE. THERE WAS NO REPORTED COMPLICATION OR ILL EFFECT SUSTAINED BY THE PT. (SEE MANUFACTURER'S REPORT NO. 6000123-2007-00010 AND 6000123-2007-00011 FOR CORRESPONDING REPORTS ON THE OTHER JAG PRECURSOR GUIDEWIRES USED IN THIS PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB EZB BOSTON SCIENTIFIC M0055658011 8836640

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR