BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL NITINOL BILLARY STENT SYSTEM

    MDR report key: 1933109 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05741
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 DURING A STENTING TREATMENT PROCEDURE, THE STENT PARTIALLY DEPLOYED. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE ADVANCING THE 6X20MM SENTINOL NITINOL BILIARY STENT SYSTEM OVER THE GUIDE WIRE, THE PHYSICIAN NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. HE NOTICED THIS PRIOR TO THE DEVICE REACHING THE INTRODUCER SHEATH AND THEREFORE REMAINED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AS THE DEVICE DID NOT ENTER THE PATIENT, NO PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493894862010

    Patients

    Seq Age Sex Outcome Treatment
    1