BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2500878 · Received March 16, 2012

    Report

    Report Number
    3005325609-2012-00007
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE THUMB SLIDE WAS IN THE DISTAL POSITION. THE TIP LUMEN OVERMOLD WAS RETURNED ALSO. WHEN EXERCISING THE RATCHETING MECHANISM, THERE WAS NO RESISTANCE NOTED. THE TIP LOT INSPECTION CONFIRMED THE OVERMOLD STRENGTH REQUIREMENTS WERE MET. THE CAUSE OF THE EVENT WAS LIKELY USER ERROR IN THAT THE USER DID NOT LOCK THE THUMB SLIDE IN THE PROXIMAL POSITION PRIOR TO WITHDRAWING THE STENT DELIVERY SYSTEM THROUGH THE INTRODUCER. IF THIS STEP IS NOT CORRECTLY FOLLOWED, THERE IS A RARE POSSIBILITY THAT THE TIP CAN CATCH ON THE INTRODUCER. A CAPA FOR THIS TYPE OF EVENT HAS BEEN OPENED. WE HAVE ISSUED A NOTIFICATION TO USERS REMINDING THEM TO ADHERE TO THE INSTRUCTIONS FOUR USE. THE PHYSICIANS ARE IN THE PROCESS OF BEING RETRAINED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT AFTER STENT DEPLOYMENT, THE TIP DETACHED FROM THE CATHETER BUT REMAINED ON THE SUPPORT WIRE. THE TIP WAS RETRIEVE WITH A SNARE DEVICE. THE PHYSICIAN BELIEVES HE RETRACTED THE THUMB SLIDE BUT DOES NOT REMEMBER LOCKING DOWN THE PROXIMAL LOCK. THE PHYSICIAN REPORTED THAT THERE WAS A TIGHT AREA WITH A SHARP ANGLE PROXIMAL TO WHERE THE STENT WAS DEPLOYED. THIS WAS DUE TO THE USE OF A REENTRY CATHETER. THE VISUAL INSPECTION REVEALED THE THUMB SLIDE WAS IN THE MAXIMUM DISTAL POSITION AND WAS NOT LOCKED WHICH INDICATES THE IFU STEP FOR REMOVING THE CATHETER WAS NOT FOLLOWED. THE IFU INSTRUCTS THE USER TO RETRACT THE THUMB SLIDE TO THE MOST PROXIMAL POSITION AND LOCK IT PRIOR TO REMOVING THE CATHETER. THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-G3 01112038

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention