BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1934727 · Received November 29, 2010

    Report

    Report Number
    3005325609-2010-00015
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG 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 (B)(4) 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 UNK IF THIS INTRODUCER WAS MANUFACTURED PRIOR TO THE PRODUCT IMPROVEMENT. THE SUPERA STENT DELIVERY SYSTEM IS CURRENTLY BEING REPLACED BY THE NEXT GENERATION DELIVERY SYSTEM WHICH INCLUDES EMBEDDED MARKER BANDS. THIS WILL ELIMINATE THIS TYPE OF MALFUNCTION FROM OCCURRING.

    Description of Event or Problem · 1

    THE TECH FULLY TIGHTENED THE INTRODUCER VALVE PRIOR TO INSERTION OF THE STENT DELIVERY CATHETER. AFTER DEPLOYING THE STENT, THE PHYSICIAN PULLED THE CATHETER BACK AND ENCOUNTERED RESISTANCE AT THE HUB OF THE INTRODUCER SHEATH. THE PHYSICIAN PULLED THE CATHETER OUT AND PROCEEDED TO PLACE A SECOND STENT. IT WAS AT THAT TIME WHEN THE PHYSICIAN OBSERVED A MARKER BAND IN THE PROXIMAL SFA (REFERENCE MDR #3005325609-2010-00014). THE PHYSICIAN PULLED THE SECOND CATHETER OUT OF THE PT RESULTING IN DISLODGING ANOTHER MARKER BAND FROM THE SECOND CATHETER IN THE HUB OF THE INTRODUCER SHEATH; THIS WAS IMMEDIATELY RETRIEVED. THE PHYSICIAN RETRIEVED THE MARKER BAND FROM THE SFA WITH A CORONARY BALLOON. 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-04-80-120-G2 00363033

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA TERUMO PINNACLE DESTINATION INTRODUCER SHEATH