BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    MDR report key: 925322 · Received March 30, 2007

    Report

    Report Number
    6000093-2007-00682
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MFG RECORDS FOR BATCH 9111850 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRM THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY AND STENTING TREATMENT PROCEDURE IN THE SFA, CATHETER REMOVAL DIFFICULTIES OCCURRED. "AFTER THEY DEPLOYED THE STENT THEY TRIED TO REMOVE THE STENT CATHETER AND IT GOT STUCK ON THE WIRE, HAD TO REMOVE THE WHOLE CATHETER AND WIRE." THE STENT CATHETER WAS INSERTED AND ADVANCED OVER THE WIRE WITHOUT DIFFICULTY. THE STENT WAS FULLY DEPLOYED, WELL APPOSED AND REMAINS IMPLANTED IN THE PATIENT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT CATHETER AFTER DEPLOYMENT, IT APPEARED THAT THE DISTAL PART OF THE DEVICE WAS CAUGHT ON THE GUIDEWIRE. THE STENT CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS A UNIT. THE PHYSICIAN WAS REQUIRED TO REGAIN ACCESS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE CURRENT PATIENT STATUS IS REPORTED AS "FINE."

    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 CORPORATION NA 9111850

    Patients

    Seq Age Sex Outcome Treatment
    1 * ROSEN GUIDEWIRE