BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2211476 · Received August 15, 2011

    Report

    Report Number
    9616099-2011-00640
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AFTER THE SMART STENT WAS IMPLANTED SUCCESSFULLY, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE THE SDS THROUGH THE NON-CORDIS SHEATH AND IT BECAME STUCK IN THE SHEATH. THE SDS HAD TO BE REMOVED TOGETHER WITH THE SHEATH AT WHICH TIME THE SHEATH BROKE. THERE WAS NO PATIENT INJURY REPORTED. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. ONE NON STERILE UNIT OF SMART CONTROL 7F 12X60 MM WAS RECEIVED COILED ALONG WITH AN UNKNOWN CATHETER SHEATH INTRODUCER (CSI) IN A PLASTIC BAG. THE DISTAL TIP-PROXIMAL END AS WELL AS THE DISTAL END OF THE CSI WERE DAMAGED (COMPRESSED). THE OUTER SHEATH WAS KINKED AT 3.0 CM FROM ID BAND. THE LOCKING PIN WAS MISSING AND BLOOD RESIDUES WERE OBSERVED AT THE HANDLE AND DISTAL TIP. NO OTHER DISCREPANCIES WERE FOUND. FUNCTIONAL ANALYSIS WAS PERFORMED USING THE INVOLVED DEVICE (UNKNOWN CSI RECEIVED ALONG WITH THE COMPLAINT UNIT) AND RESISTANCE WAS FELT AT THE INTERACTION BETWEEN THE DISTAL TIP-PROXIMAL END AND THE DISTAL END OF THE CSI (DAMAGED AREA OF BOTH DEVICES). THE OUTER DIAMETER (OD) OF THE STENT DELIVERY SYSTEM WAS MEASURED IN SEVERAL PLACES, AND IT WAS FOUND ACCEPTABLE. 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 WITHDRAWAL DIFFICULTY "THROUGH GUIDE SHEATH" REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD BE RELATED TO THE DAMAGES OBSERVED AT THE DISTAL END OF THE UNKNOWN CSI (INVOLVED DEVICE WITH THE COMPLAINT UNIT) AND AT THE PROXIMAL END OF THE SMART CONTROL DISTAL TIP. THE CAUSE OF THE DAMAGES ON THE SMART CONTROL UNIT COULD NOT BE DETERMINE DURING THE ANALYSIS; HOWEVER, IT DOES NOT APPEARS TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT DAMAGES IN THE SDS. PROCEDURAL FACTORS AND HANDLING MAY HAVE CONTRIBUTED TO FAILURE AS REPORTED. THE CAUSE OF THE KINKED CONDITION OF THE OUTER SHEATH FOUND DURING THE PRODUCT ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT COULD BE RELATED TO THE COILED CONDITION OF THE PRODUCT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGEST THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT; THEREFORE, NO CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO DEVICE INTERACTION, PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING. ONE NON STERILE UNIT OF SMART CONTROL 7F 12X60 MM WAS RECEIVED COILED ALONG WITH AN UNKNOWN CATHETER SHEATH INTRODUCER (CSI) IN A PLASTIC BAG. THE DISTAL TIP-PROXIMAL END AS WELL AS THE DISTAL END OF THE CSI WERE DAMAGED (COMPRESSED). THE OUTER SHEATH WAS KINKED AT 3.0 CM FROM ID BAND. THE LOCKING PIN WAS MISSING AND BLOOD RESIDUES WERE OBSERVED AT THE HANDLE AND DISTAL TIP. NO OTHER DISCREPANCIES WERE FOUND. FUNCTIONAL ANALYSIS WAS PERFORMED USING THE INVOLVED DEVICE (UNKNOWN CSI RECEIVED ALONG WITH THE COMPLAINT UNIT) AND RESISTANCE WAS FELT AT THE INTERACTION BETWEEN THE DISTAL TIP-PROXIMAL END AND THE DISTAL END OF THE CSI (DAMAGED AREA OF BOTH DEVICES). THE OUTER DIAMETER (OD) OF THE STENT DELIVERY SYSTEM WAS MEASURED IN SEVERAL PLACES, AND IT WAS FOUND ACCEPTABLE. 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 WITHDRAWAL DIFFICULTY "THROUGH GUIDE SHEATH" REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD BE RELATED TO THE DAMAGES OBSERVED AT THE DISTAL END OF THE UNKNOWN CSI (INVOLVED DEVICE WITH THE COMPLAINT UNIT) AND AT THE PROXIMAL END OF THE SMART CONTROL DISTAL TIP. THE CAUSE OF THE DAMAGES ON THE SMART CONTROL UNIT COULD NOT BE DETERMINE DURING THE ANALYSIS; HOWEVER, IT DOES NOT APPEARS TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT DAMAGES IN THE SDS. PROCEDURAL FACTORS AND HANDLING MAY HAVE CONTRIBUTED TO FAILURE AS REPORTED. THE CAUSE OF THE KINKED CONDITION OF THE OUTER SHEATH FOUND DURING THE PRODUCT ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT COULD BE RELATED TO THE COILED CONDITION OF THE PRODUCT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGEST THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT; THEREFORE, NO CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER THE SMART 7FR(120CM) STENT 12X60MM WAS IMPLANTED SUCCESSFULLY, IT WAS IMPOSSIBLE TO REMOVE THE STENT DELIVERY SYSTEM THROUGH THE NON-CORDIS SHEATH, AND THE STENT DELIVERY SYSTEM BECAME STUCK IN THE SHEATH. THE STENT DELIVERY SYSTEM HAD TO BE REMOVED TOGETHER WITH THE SHEATH AND THE SHEATH BROKE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    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 15360637

    Patients

    Seq Age Sex Outcome Treatment
    1 SMITH SHEATH