BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3000014 · Received March 8, 2013

    Report

    Report Number
    3005325609-2013-00007
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT AND TIP/LUMEN ASSEMBLY WERE RECEIVED LODGED IN THE INTRODUCER SHEATH BY THE SNARE DEVICE. THE TIP LUMEN HAD SEPARATED FROM THE CATHETER AT THE RATCHET STEM. F/U COMMUNICATIONS CONCLUDED THAT FLUOROSCOPY WAS NOT USED DURING THE PROCEDURE TO CONFIRM THAT THE STENT WAS FULLY DEPLOYED PRIOR TO REMOVING THE DELIVERY SYSTEM. THE THUMB SLIDE WAS APPROPRIATELY IN THE PROXIMAL AND LOCKED POSITION AS INSTRUCTED BY THE IFU. HOWEVER, THE PHYSICIAN DID NOT FULLY DEPLOY THE STENT PER THE IFU PRIOR TO REMOVING THE DELIVERY CATHETER. THE IFU INSTRUCTS THE USER TO FULLY DEPLOY THE STENT AND VIEW UNDER FLUOROSCOPY. WHEN THE THUMB SLIDE WAS MOVED PROXIMALLY AND LOCKED PRIOR TO REMOVING THE DELIVERY SYSTEM, THE PROXIMAL END OF THE STENT BECAME TRAPPED INSIDE THE DELIVERY SYSTEM. AS THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM WITH THE STENT ATTACHED, THE STENT TRAVELED INTO THE DISTAL END OF THE INTRODUCER. AS THE DELIVERY SYSTEM WITH THE ATTACHED STENT CONTINUED TO MOVE THROUGH THE INTRODUCER, THE REDUCED DIAMETER OF THE TRAPPED STENT AS IT ENTERED THE INTRODUCER ELONGATED THE TIP LUMEN AND RESULTED IN THE DETACHMENT.

    Description of Event or Problem · 1

    THE STENT WAS NOT FULLY DEPLOYED AND A PORTION OF IT WAS STILL IN THE SHEATH WHEN THE PHYSICIAN BEGAN TO REMOVE THE DELIVERY SYSTEM. THIS RESULTED IN THE TIP OF THE CATHETER BECOMING CAUGHT AND DETACHING. A SNARE DEVICE WAS USED TO BRING THE TIP INTO THE INTRODUCER SHEATH AND REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100753 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-6F 02000061

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention