BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION PROBE

    MDR report key: 1111911 · Received August 12, 2008

    Report

    Report Number
    3005099803-2008-02138
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    April 2, 2008
    Report Date
    July 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER; THEREFORE THE DEVICE MANUFACTURE DATE IS UNK. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE 2008, 15-MONTH SPYSCOPE DIRECT VISUALIZATION PROBE 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 EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT 3005099803-2008-02140 FOR A DESCRIPTION FOR THE SECOND EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON JULY 14, 2008 THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING A SPYGLASS DVS PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, THE DAY AFTER THE PROCEDURE, "THE PT EXPERIENCED ACID REFLUX." THE REPORTED SIGNS AND SYMPTOMS WERE LISTED AS: INDIGESTION, DISCOMFORT AND SENSE OF ANXIETY. THE PT WAS GIVEN MEDICATION (EXACT MEDICATION UNK) AND THE EVENT WAS RESOLVED/RECOVERED (BACK TO BASELINE LEVEL) WITHOUT SEQUELAE IN THE SAME MONTH. THE PHYSICIAN DETERMINED THAT THE EVENT WAS "MODERATE" IN SEVERITY AND ASSESSED THE EVENT AS "POSSIBLY" RELATED TO THE ERCP PROCEDURE, THE SPYGLASS DVS PROCEDURE, THE SPYSCOPE DEVICE AND THE SPYGLASS PROBE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS DIRECT VISUALIZATION PROBE KOG BOSTON SCIENTIFIC CORPORATION M00546030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other