BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3000051 · Received March 8, 2013

    Report

    Report Number
    3005325609-2013-00006
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE ANALYSIS HAD NOT BEEN COMPLETED AT THE TIME OF THIS MEDICAL DEVICE REPORT SUBMISSION. THIS IS A KNOWN PROBLEM AND A CAPA WAS PREVIOUSLY OPENED. AS A RESULT OF THE CAPA, A MINOR DEVICE MODIFICATION WAS MADE AND WAS CLEARED ON 12/07/2012 UNDER A 510 (K) (K122546). THE EVALUATION CODES PROVIDED ABOVE ARE TYPICAL FOR THIS KNOWN DEVICE ISSUE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PRIOR TO REMOVAL OF THE DELIVERY SYSTEM, THE DEVICE WAS LOCKED WITH THE THUMB SLIDE ALL THE WAY BACK. UPON REMOVAL, THE CATHETER TIP CAUGHT ON THE 6FR INTRODUCER SHEATH. THE END OF THE INTRODUCER SHEATH WAS REPORTEDLY IN A TIGHT ANGLE. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING REMOVAL. THE TIP WAS IN THE DELIVERY SYSTEM'S SHEATH WHICH WAS SUCCESSFULLY REMOVED. THERE WERE NO ADDITIONAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100366 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-060-120-6F 01432066

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INTRODUCER SHEATH: 6FR DESTINATION SHEATH| BALLOON: 7MM X 60MM MUSTANG| GUIDEWIRE: SUREPATH