BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4202697 · Received October 27, 2014

    Report

    Report Number
    1058196-2014-00271
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS ONE OF TWO PRODUCTS REPORTED UNDER COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10250065. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS ASSOCIATED WITH COMPLAINT NO. (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE ENTERPRISE STENT (ENF452800LOT / (B)(4)) HAD A LOT OF FRICTION AT PROXIMAL PORTION OF THE PROWLER SELECT PLUS CATHETER (606S255X/(B)(4)) AND ADDITIONAL FORCED WAS USED, AND THE STENT APPEARED TO DETACH IN CATHETER. THE SYSTEM WAS REMOVED AND A NEW PROWLER SELECT PLUS AND STENT WAS USED AND ALL WENT FINE. CATHETER WAS FLUSHED ON BACK TABLE AND STENT WAS PUSHED OUT OF CATHETER-ALL COMPONENTS WERE BEING RETURNED, BUT TO DATE NO DEVICES WERE RECEIVED. NO DAMAGES WERE NOTICED ON DELIVERY OR INTRODUCER, AND THE DEVICE WAS LOADED IN Y CONNECTOR. THE DEVICE WAS COMPLETELY SEATED IN MICROCATHETER HUB, AND NO ADDITIONAL TORQUE WAS USED. HOWEVER, RESISTANT OCCURRED RIGHT AT THE BEGINNING OF ADVANCING SYSTEM INTO PROWLER ALTHOUGH A SALINE DRIP WAS USED. NO DAMAGES WERE NOTICED WHEN OPENING PACKAGE, AND THE ENTERPRISE WAS USED PER LABEL FOR USE. NO SHAPING WAS DONE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXACT SIZE ENTERPRISE STENT WITH NO DIFFICULTIES. THERE WAS NO ADVERSE EVENT REPORTED AND THE COMPONENTS WERE NOT RETURNED FOR ANALYSIS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NO LOT NUMBER WAS PROVIDED FOR THE ENTERPRISE VRD, THEREFORE NO REVIEW COULD BE CONDUCTED. WITHOUT THE DEVICES THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER, BASED ON THE INFORMATION IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONAL, THERE WAS NO DEFECT NOTED WITH REVIEW OF MANUFACTURING RECORDS, THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKING AT THIS TIME. THIS REPORT IS FOR TWO DEVICES REPORTED UNDER COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ENTERPRISE STENT (ENF452800LOT /UNK) HAD A LOT OF FRICTION AT PROXIMAL PORTION OF THE PROWLER SELECT PLUS CATHETER (606S255X/16035926) AND ADDITIONAL FORCED WAS USED, AND THE STENT APPEARED TO DETACH IN CATHETER. THE SYSTEM WAS REMOVED AND A NEW PROWLER SELECT PLUS AND STENT WAS USED AND ALL WENT FINE. CATHETER WAS FLUSHED ON BACK TABLE AND STENT WAS PUSHED OUT OF CATHETER-ALL COMPONENTS ARE BEING RETURNED. NO DAMAGES WERE NOTICED ON DELIVERY OR INTRODUCER, AND THE DEVICE WAS LOADED IN Y CONNECTOR. THE DEVICE WAS COMPLETELY SEATED IN MICROCATHETER HUB, AND NO ADDITIONAL TORQUE WAS USED. HOWEVER, RESISTANT OCCURRED RIGHT AT THE BEGINNING OF ADVANCING SYSTEM INTO PROWLER ALTHOUGH A SALINE DRIP WAS USED. NO DAMAGES WERE NOTICED WHEN OPENING PACKAGE, AND THE ENTERPRISE WAS USED PER LABEL FOR USE. NO SHAPING WAS DONE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXACT SIZE ENTERPRISE STENT WITH NO DIFFICULTIES. THERE WAS NO ADVERSE EVENT REPORTED AND THE COMPONENTS WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683748 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10250065

    Patients

    Seq Age Sex Outcome Treatment
    1