BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL NITINOL BILLARY STENT SYSTEM

    MDR report key: 1822352 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03756
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    May 28, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE EXTERIOR SHAFT WAS DAMAGED/BUNCHED NEAR THE DISTAL END OF THE EXTERIOR HUB. THE DAMAGE TO THE EXTERIOR SHAFT RESTRICTED A .035" GUIDE WIRE FROM BEING TRACKED THROUGH THE LUMEN OF THE STENT DELIVERY SYSTEM AND THE INNER SUPPORT SHAFT COULD NOT BE MOVED DISTALLY THROUGH THE EXTERIOR SHAFT. VISUAL INSPECTION REVEALED THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE TO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6)-2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, DIFFICULTY LOADING THE STENT DELIVERY SYSTEM ON A GUIDE WIRE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS CEPHALIC VEIN. A ZIPWIRE WAS ADVANCED INTO THE PATIENT TO FACILITATE THE ADVANCEMENT OF THIS 10X41X750 SENTINOL BILIARY STENT. THE PHYSICIAN EXPERIENCED DIFFICULTY LOADING THE SENTINOL STENT DELIVERY SYSTEM (SDS) ONTO THE ZIPWIRE DUE TO RESISTANCE. THE SENTINOL WAS NEVER ADVANCED INTO THE PATIENT. THE SDS WAS TAKEN OFF THE WIRE AND THE ZIPWIRE WAS REMOVED FROM THE PATIENT. ANOTHER ZIPWIRE WAS ADVANCED INSIDE THE PATIENT AND ANOTHER SENTINOL STENT WAS ADVANCED TO THE LESION AND DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, PRODUCT ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL NITINOL BILLARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H7493894814070 12761291

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 035/180 ANGLED ZIPWIRE