BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 2492713 · Received January 16, 2009

    Report

    Report Number
    3005099803-2009-00200
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, GUIDE WIRE COATING DAMAGE OCCURRED. THE LOCATION OF THE LESION IS UNKNOWN. THE 0.025 JAG PRECURSOR GUIDE WIRE WAS ADVANCED THROUGH AN UNSPECIFIED CANNULA TO THE LESION AFTER WHICH THE CANNULA WAS REMOVED. AN ATTEMPT WAS MADE TO BACKLOAD AN UNSPECIFIED EST KNIFE ONTO THE GUIDE WIRE, HOWEVER, THE KNIFE WAS UNABLE TO BE LOADED AND IT WAS NOTED THAT THE PROXIMAL END OF THE GUIDE WIRE'S COATING WAS SPLIT. THE GUIDE WIRE WAS REMOVED IN EXCHANGE FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDE WIRE MDM BOSTON SCIENTIFIC M0055656011

    Patients

    Seq Age Sex Outcome Treatment
    1