BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1702877 · Received May 24, 2010

    Report

    Report Number
    3005325609-2010-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 4, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NEITHER THE STENT DELIVERY CATHETER OR THE SHEATH, 7FR TERUMO DESTINATION, WERE NOT RETURNED; THEY WERE DISCARDED. MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. BASED ON PRIOR INVESTIGATIONS OF THIS EVENT TYPE, THE CAUSE OF THE EVENT IS THE VALVE OF THE TERUMO DESTINATION SHEATH IS BELOW THE LABELED .100" MINIMUM DIAMETER OUT-OF-THE-BOX. THIS TYPE OF EVENT HAS NOT OCCURRED WITH OTHER INTRODUCER SHEATHS. THE STENT DELIVERY CATHETER IS DESIGNED AND PRODUCED TO A MAXIMUM ID OF .096 WHICH IS COMPLIANT WITH 7FR CATHETER LABELING. TERUMO HAS BEEN NOTIFIED OF THESE EVENTS. THERE HAVE BEEN NO INJURIES REPORTED RELATED TO THESE EVENTS. IN (B)(6) 2009, TERUMO NOTIFIED IDEV THAT THERE WERE CURRENTLY WORKING ON A PROCESS IMPROVEMENT THAT WOULD ADDRESS THIS EVENT TYPE. THE LOT NUMBER OF THE TERUMO SHEATH WAS NOT AVAILABLE, THEREFORE, IT IS UNKNOWN IF THIS INTRODUCER WAS MANUFACTURED PRIOR TO THE PRODUCT IMPROVEMENT. THE PHYSICIAN HAS BEEN NOTIFIED OF THIS INVESTIGATION CONCLUSION. IDEV IS CURRENTLY IN THE PROCESS OF INCORPORATING EMBEDDED MARKER BANDS IN THE STENT DELIVERY SYSTEM (AWAITING 510(K) CLEARANCE).

    Description of Event or Problem · 1

    DURING THE STENT IMPLANT INTO THE POPLITEAL, BOTH MARKER BANDS DISLODGED FROM THE STENT DELIVERY CATHETER. ONE OF THE MARKER BANDS WAS RETRIEVED USING A FILTER DEVICE. THE OTHER MARKER BAND BECAME EMBEDDED IN THE PERONEAL ARTERY AND WAS SURGICALLY REMOVED. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-40-120-G2 00301040

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R TERUMO DESTINATION SHEATH (7FR)