BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2500862 · Received March 16, 2012

    Report

    Report Number
    3005325609-2012-00006
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD CODE: EVAL WAS PERFORMED USING INFO FROM THE REP PRESENT AT THE EVENT AND ALSO PRIOR EVENTS OF THIS TYPE. THE DEVICE WAS NOT RELEASED BY THE FACILITY THEREFORE DEVICE EVAL COULD NOT BE COMPLETED. THE CAUSE OF THE EVENT WAS LIKELY USER ERROR. THE PHYSICIAN MAY NOT HAVE FOLLOWED THE IFU WHICH INSTRUCTS TO RETRACT AND LOCK THE THUMB SLIDE PRIOR TO REMOVING THE CATHETER. IF THIS STEP IS NOT CORRECTLY FOLLOWED, THERE IS A RARE POSSIBILITY THAT THE TIP CAN CATCH ON THE CATHETER SHEATH. IF THE DEVICE IS RETURNED, THE INVESTIGATION WILL PROCEED AND AN MDR SUPPLEMENT WILL BE SUBMITTED. A CAPA FOR THIS TYPE OF EVENT HAS BEEN OPENED. WE HAVE ISSUED A NOTIFICATION TO USERS REMINDING THEM TO ADHERE TO THE INSTRUCTIONS FOR USE. THE USERS ARE ALSO BEING RETRAINED ON THE USER OF THE DEVICE.

    Description of Event or Problem · 1

    AFTER SUCCESSFUL STENT DEPLOYMENT, THE TIP WAS RETRACTED AND THE "RED LEVERS" (THUMB SLIDE AND LOCK) WITH NO NOTICEABLE FORCE. UPON INSERTION OF A SECOND STENT, A "DARK SPOT" WAS OBSERVED IN THE ARTERY WHICH WAS DETERMINED TO BE THE TIP FROM THE FIRST STENT DELIVERY CATHETER USED. THE PHYSICIAN WAS UNSUCCESSFUL AT RETRIEVING THE TIP WITH A SNARE DEVICE. THE TIP LODGED IN THE PERONEAL WHERE IT WAS LEFT. THE PT WAS DOING WELL POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-04-100-120-G3 01126061

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention