BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2875734 · Received December 12, 2012

    Report

    Report Number
    3005325609-2012-00035
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE TIP OVERMOD AND THE TERUMO 7FR INTRODUCER SHEATH WERE NOT RETURNED. THERE WERE NO OTHER DEFICIENCY NOTED WITH THE DEVICE OTHER THAN THE DETACHED TIP ASSEMBLY. BASED ON PRIOR EVENTS, IT IS POSSIBLE THAT THE TIP CAUGHT ON THE INTRODUCER VALVE DUE TO INADEQUATE CLEARANCE. PT INFO WOULD NOT BE RELEASED BY THE HOSPITAL. A CAPA FOR THESE EVENTS WAS OPENED RESULTING IN A DEVICE MODIFICATION TO DECREASE THE RATE OF THESE TYPE OF EVENTS. FDA 510 (K) CLEARANCE (K122546) FOR THIS MODIFICATION WAS RECEIVED ON 12/07/2012.

    Description of Event or Problem · 1

    THE STENT WE DELIVERED AND DELAYED PROPERLY, THE PHYSICIAN PULLED BACK THE THUMB SLIDE AND ROTATED THE LOCK. DURING REMOVAL OF THE CATHETER SYSTEM AS THE CATHETER WAS COMING BACK THROUGH THE INTRODUCER SHEATH, THE TIP BECAME CAUGHT ON THE HUB OF THE SHEATH AND DETACHED. THE TIP WAS REMOVED FROM THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-080-120-G3 01127036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention