BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL SELF-EXPANDING NITINOL VASCULAR STENT SYSTEM

    MDR report key: 1790551 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03401
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EMDR WAS DUE ON (B)(4) 2010 AND WAS SUBMITTED ON (B)(4) 2010 BUT THERE WAS A DELAY IN PROCESSING ACKNOWLEDGEMENT 3 DUE TO AN FDA SERVER ISSUE WHICH MADE THE MDR APPEAR LATE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: VISUAL AND MICROSCOPIC INSPECTION REVEALED A SHAFT KINK LOCATED APPROXIMATELY 3 CENTIMETERS DISTALLY FROM THE EDGE OF THE EXTERIOR HUB. THE EXTERIOR SHAFT WAS DAMAGED ON BOTH SIDES OF THE DISTAL MARKERBAND. IT APPEARS TO BE BUNCHED UP ON THE PROXIMAL END OF THE MARKERBAND AND FLARED ON THE DISTAL END OF THE MARKERBAND. THE STENT APPEARS TO BE FULLY DEPLOYED ON ONE END AND PARTIALLY DEPLOYED ON THE OTHER END. 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 CONSIDERED HANDLING DAMAGE, AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EMDR WAS DUE ON (B)(6), 2010 AND WAS SUBMITTED ON (B)(6), 2010 BUT THERE WAS A DELAY IN PROCESSING ACKNOWLEDGEMENT 3 DUE TO AN FDA SERVER ISSUE WHICH MADE THE MDR APPEAR LATE. (B)(4): THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY (PTCA) PROCEDURE, A STENT PARTIALLY DEPLOYED. THE SENTINOL VASCULAR 6X40MM STENT WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE OUTSIDE THE PATIENT. THE STENT "GOT STUCK" AND THE COVER MOVED, LEAVING THE PROXIMAL THIRD OF THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY (PTCA) PROCEDURE, A STENT PARTIALLY DEPLOYED. THE SENTINOL VASCULAR 6X40MM STENT WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE OUTSIDE THE PATIENT. THE STENT "GOT STUCK" AND THE COVER MOVED, LEAVING THE PROXIMAL THIRD OF THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY (PTCA) PROCEDURE, A STENT PARTIALLY DEPLOYED. THE SENTINOL VASCULAR 6X40MM STENT WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE OUTSIDE THE PATIENT. THE STENT "GOT STUCK" AND THE COVER MOVED, LEAVING THE PROXIMAL THIRD OF THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL SELF-EXPANDING NITINOL VASCULAR STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H7493894964010 13061819

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR