BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1375283 · Received February 20, 2009

    Report

    Report Number
    3005325609-2009-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 22, 2009
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICES WERE DISCARDED AT THE HOSPITAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED WITH THE DEVICE'S LOT OR MANUFACTURING PROCESSES. THIS EVENT WAS THE FIRST REPORTED EVENT WHERE A MARKER BAND DISLODGED AND IT REMAINED IN THE PATIENT. PREVIOUS INVESTIGATIONS REGARDING THIS TYPE OF EVENT HAVE CONCLUDED THAT THE REPORTED MARKER BAND MOVEMENT/DISLODGEMENT EVENTS ARE RELATED TO THE USE OF ONE TYPE OF INTRODUCER SHEATH (SAME MANUFACTURER AND SAME BRAND NAME) WITH THE STENT DELIVERY CATHETER. WE HAVE RECEIVED TWO OF THE INTRODUCER SHEATH'S BACK FOR ANALYSIS AND FOUND THAT WHEN THIER VALVE IS TIGHTENED, A PIN GAUGE TEST RESULTS IN LESS THAN 7FR. THIS TIGHTNESS RESULTS IN THE SHEATH CATCHING THE MARKER BAND CAUSING IT TO MOVE/DISLODGE. THE MANUFACTURE OF THE SHEATH HAS BEEN INFORMED OF THE EVENTS. THERE HAVE BEEN NO SERIOUS INJURIES OR DEATHS RELATED TO THESE EVENTS.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE HUB ON THE INTRODUCER SHEATH WAS TOO TIGHT AND CAUSED ONE OF THE MARKER BANDS TO COME OFF OF THE STENT DELIVERY CATHETER. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO RETRIEVE THE MARKER BAND. THE PHYSICIAN DEVIDED THAT SINCE THE MARKER BAND HAD LODGED IN A DEAD END VESSEL OFF THE PROFUNDA THAT IT WOULD HAVE NO LONG-TERM CLINICAL RELEVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-G2 F00253038

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SHEATH: 7F PINNACLE