BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4324097 · Received December 11, 2014

    Report

    Report Number
    1058196-2014-00307
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 22, 2014
    Report Date
    January 26, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS REPORTED UNDER COMPLAINT NO. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR ANALYSIS.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE STENT (ENF452812/10401516) DID NOT ADVANCED IN THE PROWLER SELECT (MC) MICROCATHETER DURING USE IN THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENTS WILL BE RETURNED FOR ANALYSIS. A NON-STERILE UNIT OF ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM WAS RECEIVED INSIDE OF A PLASTIC BAG. INSIDE OF THE PLASTIC BAG ONLY THE STENT WAS RECEIVED DEPLOYED. INVOLVED MICROCATHETER WAS ANALYZED UNDER (B)(4); THE INVOLVED DELIVERY WIRE WAS NOT RECEIVED FOR ANALYSIS. NO ANOMALIES WERE FOUND DURING VISUAL ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE STENT INVOLVED WAS RECEIVED DEPLOYED. IN ORDER TO PERFORM THE TEST IT IS REQUIRED THE INVOLVED DELIVERY AND THIS COMPONENT WAS NOT RECEIVED FOR ANALYSIS. STENT WAS ANALYZED UNDER VISION SYSTEM AND NO ANOMALIES WERE FOUND. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10401516. 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. THE REPORTED FAILURE BY THE CUSTOMER AS ¿DELIVERY WIRE / IMPEDED WITH LOSS OF CEREBRAL TARGET POSITION¿ WAS NOT CONFIRMED SINCE THE PRODUCT COULD NOT BE PROPERLY EVALUATED SINCE ONLY THE STENT WAS ONLY COMPONENT RECEIVED FOR ANALYSIS. THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, PROCEDURAL / HANDLING FACTORS MIGHT HAVE CONTRIBUTED TO THOSE ISSUES. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE ENTERPRISE STENT (ENF452812/1041516) DID NOT ADVANCED IN THE PROWLER SELECT (MC) MICROCATHETER DURING USE IN THE PATIENT. 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
    804945 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1