BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3813515 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02608
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A LIBERTE STENT DELIVERY SYSTEM (SDS) AND STENT WITH A LIBERTE SHELF BOX AND PRODUCT POUCH. THE BATCH NUMBER ON THE RETURNED PACKAGING AND DEVICE MATCHED THE REPORTED BATCH NUMBER. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WAS A COMPLETE HYPOTUBE SEPARATION 60.5CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THERE WERE MULTIPLE KINKS THROUGHOUT THE HYPOTUBE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 DEVICE ANALYSIS COMPETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. A 2.75MM X 16MM LIBERTÉ STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291362 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816270 16006298

    Patients

    Seq Age Sex Outcome Treatment
    1