BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2503406 · Received March 21, 2012

    Report

    Report Number
    3005325609-2012-00008
    Event Type
    Other
    Date Received
    March 21, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR 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, MFG 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 MFG OF THE DEVICE. THE PHYSICIAN HAD BEEN TRAINED ON THE USE OF THE DELIVERY SYSTEM IN AUGUST 2011. 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. THE CAUSE OF THE EVENT WAS DISCUSSED WITH THE PHYSICIAN. 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

    AFTER SUCCESSFUL STENT DEPLOYMENT IN THE RIGHT POPLITEAL ARTERY, THE CATHETER TIP BECAME DISLODGED WHILE REMOVING THE CATHETER. THE TIP WAS RETRIEVED. THERE WAS NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-040-120-6F 01189057

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention