BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1052538 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00528
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 21, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT A MDR-REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE , WHICH WAS COMPLETED ON MAY 15, 2008, REVEALED A MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BASED ON THE EVALUATION RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS FULLY MOUNTED AND THAT THE OUTER SHEATH WAS RETRACTED 5MM FROM THE TIP. SEVERAL STENT WIRES HAD PERFORATED THE OUTER SHEATH (SEE FIGURE 1, PAGE 3). THE INVESTIGATION ALSO REVEALED THAT THE OUTER SHEATH WAS KINKED AT THE GUIDEWIRE ACCESS PORT. THE CAUSE OF THE DAMAGE IS UNKNOWN. A FUNCTIONAL EXAMINATION REVEALED THAT A GUIDEWIRE WAS NOT ABLE TO BE ADVANCED THROUGH THE GUIDEWIRE ACCESS POINT DUE TO THE KINK IN THE OUTER SHEATH. THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THREE ADDITIONAL COMPLAINTS REPORTED FOR THE LOT (FOR THE SAME FAILURE MODE). AN APRIL 2008 15 MONTH RX BILIARY STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN "WAS UNABLE TO INSERT THE DEVICE COMPLETELY DUE TO RESISTANCE. [AFTER DEVICE REMOVAL], THE DEVICE WAS FOUND TO BE KINKED [AT] THE [GUIDEWIRE] EXIT PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT (MANUFACTURER UNKNOWN). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD. M00569710 11365293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK