BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE GUIDEWIRE

    MDR report key: 1211084 · Received October 24, 2008

    Report

    Report Number
    3005099803-2008-05489
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FOURTH OF FIVE DEVICES REPORTED FOR THE EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON SEPTEMBER 24, 2008, THAT A DISTAL BILE DUCT PERFORATION WAS OBSERVED AFTER A PROCEDURE PERFORMED ON APPROX TWO MONTHS EARLIER, USING A JAGWIRE GUIDEWIRE. THE PT WAS ADMITTED TO THE HOSPITAL AND LATER RELEASED; THE PT'S CONDITION WAS REPORTED TO BE "FINE." ACCORDING TO THE COMPLAINANT, THE RELATIONSHIP BETWEEN THE DUCT PERFORATION AND THE JAGWIRE DEVICE IS UNK. REFER TO MFR REPORTS #3005099803-2008-05484, 3005099803-2008-05485, 3005099803-2008-05486, AND 3005099803-2008-05488 FOR THE OTHER FOUR DEVICES USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M00556581 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O