BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT

    MDR report key: 1081536 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01292
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: CUSTOMER COMPLAINT OF THE GUIDE CATHETER BEING STRETCHED CONFIRMED. YELLOW RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. THE STENT WAS NOT RETURNED FOR EVAL. TWO PIECES OF THE GUIDE CATHETER WERE RETURNED, ONE BEING INSIDE THE PUSH CATHETER. THE GUIDE CATHETER HUB WAS DETACHED AND NOT RETURNED FOR EVAL. THE PUSH CATHETER WAS FOUND TO BE TWISTED AT THE HUB. A VISUAL EVAL FOUND THAT THE PUSH CATHETER WAS ACCORDION AND KINKED. THE GUIDE CATHETER WAS TORN IN TWO PLACES. A LOT HISTORY SEARCH WAS NOT PERFORMED DUE TO THE LOT NUMBER NOT BEING PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DUE TO THE LOT NUMBER NOT BEING PROVIDED. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE INVESTIGATION COMPLETED IN 2008. THE TARGET LESION WAS IN AN UNSPECIFIED BILIARY LOCATION. A 7F/7CM FLEXIMA BILIARY STENT HAD BEEN ADVANCED TO THE TARGET LESION. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE INNER CATHETER WAS "STRETCHED". THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DIFFERENT DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD". THE RETURNED DEVICE REVEALED A BROKEN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT FGE BOSTON SCIENTIFIC M00539210

    Patients

    Seq Age Sex Outcome Treatment
    1