BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3202192 · Received June 28, 2013

    Report

    Report Number
    3005325609-2013-00020
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE CATHETER TIP OVERMOLD HAD SEPARATED FROM THE TIP LUMEN. THE STENT HAD NOT BEEN DEPLOYED. THE DEVICE WAS EXERCISED AND NO ANOMALIES WERE NOTED. THE TIP LUMEN DID NOT SHOW EVIDENCE OF NECKING OR A KINK. THE TIP LUMEN SHOWED DAMAGE AT THE INTERFACE OF THE TIP OVERMOLD TO THE LUMEN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. TENSILE STRENGTH SAMPLES WERE REVIEWED AND THEY HAD PULL STRENGTHS WELL ABOVE THE MINIMUM SPECIFICATION LIMIT. FROM THE ANALYSIS, THERE IS EVIDENCE THAT THE TIP OVERMOLD DETACHED DUE TO INTERACTION OF THE PROXIMAL END OF THE OVERMOLD WITH AN OBJECT. THE CAUSE OF THE EVENT WAS NOT FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE STENT WAS BEING LOADED ONTO A 0.018 GUIDEWIRE, THE TIP DETACHED FROM THE CATHETER. ANOTHER SUPERA DEVICE WAS THEN USED WITH NO ISSUES. THERE WAS NO INTERACTION WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295921 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-04-080-120-6F 01321053

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR