BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1180986 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04927
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NURSE OPENED THE BOX DURING UNPACKING, THERE WAS ONLY ONE DEVICE PRESENT. THERE SHOULD BE TWO DEVICES IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658011 0011672447

    Patients

    Seq Age Sex Outcome Treatment
    1