BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ VASCULAR SD

    MDR report key: 3093497 · Received May 6, 2013

    Report

    Report Number
    2134265-2013-02896
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT HAD MOVED ON THE BALLOON 2MM PROXIMALLY FROM THE DISTAL MARKERBAND AND THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE TIGHTLY FOLDED BALLOON INDICATED THE DEVICE WAS SUBJECTED TO NO POSITIVE (INFLATION) PRESSURE. THE FIRST DISTAL STENT STRUT ROW HAD STRUTS STRETCHED AND BENT. THERE WERE MULTIPLE SHAFT KINKS 25.5CM TO 26.5CM FROM THE DISTAL TIP. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION 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 COMPLETED ON (B)(4)-2013.IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A CATHETER WAS FOUND KINKED. THE 6.0MM X 18MM X 90 CM EXPRESS VASCULAR SD WAS SELECTED FOR RENAL STENTING BUT WAS THE CATHETER WAS FOUND TO BE KINKED AND THE DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WEE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE AND THAT THE STENT HAD MOVED ON THE BALLOON. THIS PRODUCE IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196673 EXPRESS¿ VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937918618900 15529756

    Patients

    Seq Age Sex Outcome Treatment
    1