BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3010866 · Received March 14, 2013

    Report

    Report Number
    3005325609-2013-00008
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. WHEN THE DEVICE WAS RECEIVED, IT WAS CONFIRMED THAT THE THUMB SLIDE WAS NOT IN THE PROXIMAL POSITION AND LOCKED AS INSTRUCTED IN THE IFU. THE DEVICE WAS EXERCISED AND THERE WERE NO ISSUES NOTED. REMOVAL OF THE DELIVERY SYSTEM OCCURRED WITHOUT THE AID OF FLUOROSCOPY AS INSTRUCTED IN THE IFU. THE TIP DETACHMENT WAS NOTED DURING THE ANGIOGRAM OF THE TREATED VESSEL. A SNARE DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE TIP. THE DETACHMENT WAS LIKELY CAUSED BY THE TIP CATCHING ON THE INTRODUCER SHEATH AS THE TIP WAS NOT PULLED BACK AND LOCKED AS INSTRUCTED. THE PHYSICIAN HAS BEEN RETRAINED. THIS IS A KNOWN EVENT AND A MINOR DESIGN CHANGE WAS MADE TO CORRECT THIS TYPE OF EVENT. A CAPA WAS OPENED FOR THIS TYPE OF EVENT AND RESULTED IN A DESIGN CHANGE THAT WAS CLEARED BY FDA ON 12/07/2012 UNDER 510(K), K122546. THIS DEVICE WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CATHETER DETACHED AND DISLODGED INTO THE PT'S TIBIO PERONEAL TRUNK FOLLOWING STENT DEPLOYMENT. FOLLOW-UP CONCLUDED THAT THE THUMB SLIDE WAS NOT ROTATED AND LOCKED AS INSTRUCTED BY THE IFU PRIOR TO REMOVING THE DELIVERY SYSTEM WHICH LIKELY CAUSED THE TIP TO CATCH ON THE INTRODUCER SHEATH. A SNARE DEVICE WAS UNSUCCESSFUL IN AN ATTEMPT TO REMOVE THE TIP. THERE WAS NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108235 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-100-120-6F 01445068

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention