BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1660753 · Received April 14, 2010

    Report

    Report Number
    3005325609-2010-00005
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 19, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE CATHETER WAS RETURNED AND ANALYZED. THE STENT HAD BEEN DEPLOYED. THE INTRODUCER, 7FR TERUMO DESTINATION, WAS NOT RETURNED. THE DISTAL MARKER BAND WAS NOT PRESENT ON THE STENT DELIVERY CATHETER; THE PROXIMAL MARKER BAND WAS IN THE CORRECT LOCATION. THE DIMENSIONS WERE MEASURED AND WERE WITHIN THE REQUIRED SPECIFICATIONS. THE MARKER BAND SWAGING EQUIPMENT RECORDS WERE REVIEWED AND THERE WERE NO ISSUES NOTED THAT WOULD HAVE LED TO THE EVENT. THE MARKER BAND LOT NUMBER RECEIVING RECORDS WERE REVIEWED AND NO ANOMALIES NOTED. THE ADDITIONAL FORCE APPLIED BY THE PHYSICIAN WHEN REMOVING THE CATHETER WAS THE CAUSE OF THE DISLODGED MARKER BAND. 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 09/2009, TERUMO NOTIFIED IDEV THAT THERE WERE CURRENTLY WORKING ON A PROCESS IMPROVEMENT THAT WOULD ADDRESS THIS EVENT TYPE. THE LOT NUMBER OF THE TERUMO INTRODUCER WAS NOT AVAILABLE, THEREFORE, IT IS UNK 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.

    Description of Event or Problem · 1

    WHILE WITHDRAWING THE CATHETER THROUGH THE VALVE OF THE INTRODUCER SHEATH, THERE WAS SOME RESISTANCE FELT AND WITH ADDITIONAL FORCE THE CATHETER WAS REMOVED. FOLLOWING THE REMOVAL OF THE CATHETER, THE PHYSICIAN OBSERVED THE CATHETER'S MARKER BAND HAD DISLODGED AND WAS IN THE PT'S VESSEL. THE MARKER BAND TRAVELED TO THE PERONEAL ARTERY AND THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO RETRIEVE IT WITH A LOOPED GUIDEWIRE. SINCE THERE WAS GOOD OUTFLOW THROUGH THE ARTERY, THE PHYSICIAN DID NOT ATTEMPT ANY SUBSEQUENT INTERVENTION. THIS EVENT OCCURRED IN (B)(6). THE DEVICE HOLDS THE CE MARK FOR THE INDICATION OF THE PERIPHERAL VASCULATURE IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-06-150-120-G2 00305045

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR GUIDEWIRE: .018 ABBOTT STEELCORE| SHEATH: 7FR TERUMO DESTINATION