BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2033561 · Received March 30, 2011

    Report

    Report Number
    9616099-2011-00210
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE FIELD INDICATED THAT AFTER THE PHYSICIAN DEPLOYED THE SMART CONTROL 9 X 60 STENT, AS HE WAS WITHDRAWING THE STENT DELIVERY SYSTEM PARTS OF THE GUIDEWIRE LUMEN/INNER SHAFT CAME APART ON THE .035 AMPLATZ GUIDEWIRE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON STERILE UNIT OF SMART CONTROL 9X80 MM WAS RECEIVED COILED IN A PLASTIC BAG. STENT, LOCKING PIN AND BRITE TIP WERE NOT RECEIVED. TWO SEGMENTS OF WIRE-LUMEN WITH 23.5 CM AND 27.2 CM OF LENGTH RESPECTIVELY WERE RECEIVED DETACHED FROM THE CATHETER OUTER SHEATH. THE WIRE-LUMEN SEGMENTS EXHIBITED ELONGATIONS AND WERE FRAYED AT THE RUPTURE POINTS. OUTER SHEATH WAS CRACKED AT 1.4 CM AND AT 12.7 CM FROM ID BAND. WIRE LUMEN WAS OBSERVED AT THE CRACKED POINTS OF THE OUTER SHEATH. ADDITIONALLY FRAYED AND TWISTED CHARACTERISTICS WERE DETECTED AT THE CRACKED LOCATIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE "GUIDE WIRE-LUMEN SEPARATED" REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE CONDITION OF THE CATHETER AS RECEIVED. HOWEVER, THE CAUSE COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. PRESENCE OF WIRE LUMEN AT THE CRACKED LOCATIONS CONFIRMED THAT GUIDE WIRE-LUMEN WAS PROPERLY ADHERED TO THE HUB AND THAT THE SEPARATION POINT OF THE WIRE-LUMEN DID NOT HAPPEN WHERE THESE COMPONENTS JOIN. IN REGARDS TO THE CRACKED CONDITION FOUND ON OUTER SHEATH, IT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PROCEDURAL FACTORS AND THE HEAVY MANIPULATION OF THE CATHETER DURING THE PROCEDURE MAY CONTRIBUTE TO THE FAILURE AS REPORTED. NEITHER THE DHR RESULTS NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT. CONTROLS EXIST THROUGH THE SDS ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT THEM IN THE SDS, REFERENCE PROCEDURES DOCUMENTED IN ROUTE SHEET # (B)(4); THEREFORE, NO CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS, DEVICE INTERACTION AND/OR USER HANDLING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT AFTER THE PHYSICIAN DEPLOYED THE SMART CONTROL 9 X 60 STENT, AS HE WAS WITHDRAWING THE STENT DELIVERY SYSTEM PARTS OF THE GUIDEWIRE LUMEN/INNER SHAFT CAME APART ON THE .035 AMPLATZ GUIDEWIRE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15222339

    Patients

    Seq Age Sex Outcome Treatment
    1 AMPLATZ .035 MM GUIDEWIRE