BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2045753 · Received April 8, 2011

    Report

    Report Number
    9616099-2011-00234
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF COMPLAINT LOT 15189322 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15189322. PRODUCT CONFIGURATION, FPI, LPI, AND RECONCILIATION OF LABELS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE ROUTER PRODUCT DESCRIPTION WAS COMPARED AGAINST FPI AND LPI INNER AND OUTER LABELS ATTACHED ON ROUTER AND NO ANOMALIES WERE FOUND. REVIEW OF THE LOT 15189323 MANUFACTURED BEFORE COMPLAINT LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ONE UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF LOT 15189323. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. REVIEW OF THE LOTS 15190481 MANUFACTURED AFTER COMPLAINT LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FIVE UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF LOT 15190481. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED. WHEN THE PHYSICIAN OPENED THE PACKAGE, HE FOUND THE PRODUCT CODE AND LOT NO. INFO WAS NOT CONSISTENT WITH THE OUTER PACKAGE. THE DEVICE WAS RETURNED FOR INVESTIGATION. WHEN THE PHYSICIAN OPENED THE FIRST PRODUCT'S INNER POUCH, HE FOUND THE STENT LENGTH WAS NOT CORRECT AS STATED ON THE OUTER PACKAGE. THEN HE OPENED THE SECOND PRODUCT'S PACKAGE AND FOUND THE SAME ISSUE. TWO UNITS OF SMART CONTROL WERE RECEIVED FOR PRODUCT ANALYSIS IN TWO OPEN BOXES. THE UNIT # 1, A SMART CONTROL 10X20 MM WAS INSIDE OF A SEALED POUCH. THE LABEL IN THE POUCH (LOT 15193983, SMART CONTROL 10X20 MM) DID NOT MATCH THE LABEL OF THE BOX (LOT 15189322, SMART CONTROL 10X60MM). NO OTHER ANOMALIES WERE NOTED. UNIT # 2, A SMART CONTROL 10X20 MM, WAS RECEIVED COILED INSIDE OF AN OPEN ENVELOPE THAT WAS INSIDE OF A BOX LABELED AS LOT 15189322, SMART CONTROL 10X60 MM. THE UNIT IN THE ENVELOPE DID NOT MATCH THE LABEL OF THE OUTER BOX. THE OUTER SHEATH WAS KINKED AT 6.5 CM FROM THE ID BAND. DHR REVIEW OF COMPLAINT LOTS 15189322 AND 15193983 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE LABEL INCORRECT CONDITION REPORTED BY THE CUSTOMER WAS CONFIRMED IN BOTH UNITS RECEIVED FOR ANALYSIS; A RISK ASSESSMENT HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN OPENED THE PACKAGE, HE FOUND THE PRODUCT CODE AND LOT NUMBER INFORMATION WAS NOT CONSISTENT WITH THE OUTER PACKAGE. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE INNER PACKAGE PRODUCT WAS NOT CONSISTENT WITH THE OUTER PACKAGE PRODUCT. THE BOXES WERE NOT OPENED AND PRODUCT WAS NOT TAKEN OUT OF STORAGE. WHEN THE PHYSICIAN OPENED THE FIRST PRODUCT'S INNER POUCH, HE FOUND THE STENT LENGTH WAS NOT CORRECT AS STATED ON THE OUTER PACKAGE. THEN HE OPENED THE SECOND PRODUCT'S PACKAGE AND FOUND THE SAME ISSUE. THE FIRST PRODUCT'S INNER POUCH WAS DISCARDED BY THE HOSPITAL. THE OUTER AND INNER STERILE PACKAGE DID NOT HAVE THE SAME LABELING.

    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 15189322

    Patients

    Seq Age Sex Outcome Treatment
    1