BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1000621 · Received February 15, 2008

    Report

    Report Number
    9616099-2008-00373
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS A KINK FOUND NEAR THE HANDLE OF THE STENT DELIVERY SYSTEM. IT WAS NOTICED WHEN OPENING THE PACKAGING. THE PACKAGING WAS INTACT BEFORE BEING OPENED. THE PRODUCT WAS NOT USED IN THE PT. ONE NON-STERILE SMART CONTROL 6X40MM WAS RECEIVED COILED. THE STENT WAS MOUNTED ON ITS ORIGINAL POSITION. THE OUTER BODY WAS BROKEN-NOT COMPLETELY- CLOSE TO THE ID BAND. NO OTHER VISUAL ANOMALIES ON THE TIP OR THE BODY WERE NOTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE REPORTED KINK WAS NOT CONFIRMED. THE CAUSE OF THE BROKEN BODY COULD NOT BE DETERMINED. IT MAY HAVE OCCURRED AFTER MANUFACTURING PROCESS, DURING SHIPPING, HANDLING OR STORAGE OF THE UNITS. A MEETINGS WAS HELD WITH THE PRODUCT ENGINEERING TEAM IN ORDER TO DETERMINE IF THIS TYPE OF FAILURE MAY HAVE OCCURRED DURING MANUFACTURING PROCESS. THE ATTENDEES REVIEWED THE RETURNED UNIT AND STATED THAT THIS TYPE OF DAMAGE COULD NOT OCCUR DURING THE COMMON HANDLING DURING THE MANUFACTURING PROCESS. IN ADDITION, INSPECTION IS IN PLACE TO PREVENT DAMAGED CATHETERS FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION WILL BE REQUESTED AT THIS TIME BECAUSE THE DAMAGED UNIT DOES NOT APPEAR TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 1

    THE ORIGINAL COMPLAINT RECEIVED STATES THAT THERE WAS A KINK FOUND NEAR THE HANDLE OF THE STENT DELIVERY SYSTEM. IT WAS NOTICED WHEN OPENING THE PACKAGING. THE PACKAGING WAS INTACT BEFORE BEING OPENED. THE PRODUCT WAS NOT USED IN THE PT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. THE PRODUCT WAS RECEIVED COILED IN A PLASTIC BAG. THE ANALYSIS SHOWED THAT THE OUTER BODY WAS BROKEN, BUT NOT COMPLETELY SEPARATED, CLOSE TO THE ID BAND. NO OTHER VISUAL ANOMALIES ON THE TIP OR THE BODY WERE NOTED. ADDITIONAL INFO FROM THE AFFILIATE STATES THAT THE PHYSICIAN DID NOT NOTICE THE DEFECT PRIOR TO OPENING THE PACKAGE. ALSO, THE PRODUCT WAS IN THIS CONDITION PRIOR TO SHIPPING FOR EVALUATION.

    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 X0106637

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK