BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1645791 · Received March 19, 2010

    Report

    Report Number
    3005325609-2010-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 23, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE STENT DELIVERY CATHETER WAS RETURNED AND ANALYZED. THE TERUMO INTRODUCER WAS NOT RETURNED AND COULD NOT BE OBTAINED. THE DIAMETER OF THE OUTER SHEATH IN THE LOCATION OF THE MARKER BANDS WERE MEASURED AND WITHIN SPECIFICATIONS. THE ASSEMBLY MFG PROCESS AND EQUIPMENT RECORDS FOR THE MARKER BAND SWAGER WERE REVIEWED AND NO ISSUES WERE NOTED. PROCESS MONITORING RECORDS AND DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED THAT WOULD HAVE LED TO THE REPORTED COMPLAINT. THE MARKER BAND LOT NUMBER RECEIVING RECORDS WERE REVIEWED AND NO ANOMALIES NOTED; THE LOT PASSED INCOMING INSPECTION FOR INNER/OUTER DIAMETER. BASED ON PRIOR EVENTS OF THIS TYPE, IDEV INVESTIGATION HAS FOUND THAT THE 7FR TERUMO INTRODUCER SHEATHS WERE BELOW THE LABELED .100" MINIMUM DIAMETER OUT-OF-THE-BOX. THIS TYPE OF EVENT HAS NOT OCCURRED WITH OTHER INTRODUCER SHEATHS. A PREVIOUS CAPA WAS ISSUED FOR THESE EVENTS WHICH INCLUDED SPEAKING WITH TERUMO MANAGEMENT. IN SEPTEMBER, 2009, TERUMO INFORMED IDEV THAT THEY WERE IN THE PROCESS OF A MODIFYING THE VALVE WHICH SHOULD CORRECT THIS TYPE OF EVENT FROM OCCURRING. SINCE WE WERE UNABLE TO GET THE LOT NUMBER OF THE TERUMO DEVICE, IT IS UNK IF THE PHYSICIAN USED AN OLD TERUMO DEVICE OR ONE WITH THE MODIFIED VALVE. TERUMO HAS BEEN NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN MADE SEVERAL ATTEMPTS TO INSERT THE STENT DELIVERY CATHETER INTO THE 7FR TERUMO DESTINATION SHEATH. HE WAS NOT ABLE TO ADVANCE IT SO, HE REMOVED IT AND USED ANOTHER SUPERA STENT DELIVERY CATHETER. HE WAS ABLE TO ADVANCE THE SECOND DELIVERY CATHETER. AFTER HE DEPLOYED THE STENT, HE NOTICED AN ARTIFACT IN THE VESSEL. IT WAS DETERMINED THAT A MARKER BAND FROM THE FIRST STENT DELIVERY CATHETER HAD DISLODGED. THE PHYSICIAN USED A BALLOON TO RETRIEVE THE MARKER BAND. THERE WAS NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-60-120-G2 00319041

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GUIDEWIRE: V18, SHEATH: 7FR TERUMO DESTINATION