BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2483089 · Received March 6, 2012

    Report

    Report Number
    3005325609-2012-00005
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND VISUAL INSPECTION CONFIRMED THAT THE THUMB SLIDE WAS IN THE DISTAL POSITION RATHER THAN THE CORRECT PROXIMAL POSITION, AND IT WAS NOT LOCKED. MECHANICALLY, THE SYSTEM WAS OPERATING PROPERLY. THERE IS NO EVIDENCE OF DESIGN, MANUFACTURING OR VENDOR DEFICIENCY. A REVIEW OF THE TIP LOT CONFIRMS THE OVERMOLD JOINT STRENGTH REQUIREMENTS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT INDICATE ANY ISSUES DURING MANUFACTURING OF THE DEVICE. THE PHYSICIAN HAD BEEN TRAINED ON USE OF THE DELIVERY SYSTEM ON 02/16/2012. THE PHYSICIAN WAS RETRAINED FOLLOWING THIS EVENT. THE CAUSE OF THE EVENT WAS USER ERROR. THE PHYSICIAN DID NOT FOLLOW 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 INTRODUCER SHEATH. 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.

    Description of Event or Problem · 1

    THE DELIVERY SYSTEM DEPLOYED THE STENT WITHOUT ANY PROBLEM. DEPLOYMENT OCCURRED IN THE ILIAC ARCH. UPON REMOVAL OF CATHETER, THE TIP DISLODGED AS IT CAME IN CONTACT WITH THE INTRODUCER SHEATH. AFTER THE PROCEDURE, THE DELIVERY SYSTEM WAS INSPECTED AND IT WAS NOTED THAT THE THUMB SLIDE WAS IN THE FORWARD POSITION (DISTALLY AND NOT RETRACTED AND LOCKED IN PLACE AS REQUIRED PER THE IFU). THE IFU INSTRUCTS THE USER TO RETRACT THE THUMB SLIDE AND LOCK IT PRIOR TO REMOVING THE CATHETER; THIS WAS NOT DONE IN THIS EVENT. FOLLOWING THE EVENT, THE IFU WAS REVIEWED WITH THE PHYSICIAN. THE TIP WAS NOT RETRIEVED AND RESIDES IN MINOR BRANCH OF THE PROFUNDA. NO INTERVENTION IS PLANNED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-080-120-G3 01127043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other