BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE ACCESS AND DELIVERY CATHETER

    MDR report key: 1080873 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01236
    Event Type
    Death
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. THE MAY 2008 15-MONTH SPYSCOPE ACCESS AND DELIVERY CATHETER PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE PROCEDURE. REFER TO MFR REPORT #3005099803-2008-01235 FOR DETAILS REGARDING THE SECOND DEVICE. A SPYGLASS DIRECT VISUALIZATION PROBE DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE PT BEGAN TO DESATURATE. THE PT CODED AND CPR WAS PERFORMED FOR APPROX 20 MINUTES. PATIENT COULD NOT BE REVIVED." FOLLOW-UP INFO ASCERTAINED FROM THE PHYSICIAN REVEALED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE SPYGLASS DEVICE. THE PRIMARY AND SECONDARY CAUSES OF DEATH ARE UNKNOWN; REQUEST FOR AUTOPSY RESULTS AND/OR AUTOPSY REPORT HAVE BEEN TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYSCOPE ACCESS AND DELIVERY CATHETER KOG BOSTON SCIENTIFIC CORPORATION M00546230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death