BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATHFINDER EXCHANGE GUIDEWIRE

    MDR report key: 841632 · Received April 25, 2007

    Report

    Report Number
    6000123-2007-00018
    Event Type
    Injury
    Date Received
    April 25, 2007
    Date of Event
    March 19, 2007
    Report Date
    March 28, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    PMA / PMN Number
    K943737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. TWO POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE INVOLVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THE PERTINENT LOTS. THE MARCH 2007 15-MONTH TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 03/28/07, THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (PATIENT AGE AND GENDER UNKNOWN) USING A PATHFINDER EXCHANGE GUIDEWIRE, THE "GUIDEWIRE UNRAVELED, [AND THE] CORE CAME OFF INSIDE THE PATIENT". THE PHYSICIAN RETRIEVED THE CORE AND SUCCESSFULLY FINISHED THE PROCEDURE USING A JAGWIRE. THE PATIENT'S CONDITION WAS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER EXCHANGE GUIDEWIRE KOG KOG BOSTON SCIENTIFIC M00551591 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention