BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 1181522 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02777
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    July 21, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED THAT THE CATHETER HAD SEVERE SHAFT DAMAGE. THE SENTINOL DELIVERY SYSTEM AND THE STENT WERE RETURNED FOR ANALYSIS. THE STENT WAS RECEIVED SEPARATELY . THE STENT WAS FULLY EXPANDED WITH TWO CELLS ON ONE END THAT HAD TISSUE PRESENT. THE DAMAGE ON THE SHAFT INCLUDED SEVERAL SEGMENTS THAT WERE FLATTENED AND COMPRESSED. THERE WERE ALSO NUMEROUS KINKS ON THE SHAFT. THE MANUFACTURING RECORDS FOR THIS BATCH NUMBER WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED UPON FOLLOW UP INFO RECEIVED IN 2008. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, ADVANCEMENT AND DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. THE 75% STENOTIC AND MINIMALLY CALCIFIED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING DILATION OF THE LESION WITH A POLAR CATHETER, THE SENTINOL BIL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER ANOTHER MANUFACTURER'S GUIDE WIRE. HOWEVER, DURING ADVANCEMENT, THE COATING OF THE GUIDE WIRE WAS COMPROMISED, AND THE SENTINOL SDS "BUCKLED". THE STENT WAS UNABLE TO BE COMPLETELY DEPLOYED. SO THE STENT, SDS AND THE GUIDE WIRE WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SENTINOL SDS AND A MAGIC TORQUE GUIDE WIRE. PATIENT STATUS WAS REPORTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11719516

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR TERUMO WIRE