BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3162540 · Received June 11, 2013

    Report

    Report Number
    1058196-2013-00157
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10086764. 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 PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: HEADWAY 27 CATHETER (DETAILS UNKNOWN); REBAR 27 MICROCATHETER (DETAILS UNKNOWN); 2 ENTERPRISE STENTS (DETAILS UNKNOWN); SECOND ENTERPRISE VRD AND DELIVERY (ENC452212/10086764).

    Additional Manufacturer Narrative · 1

    THE FIRST ENTERPRISE VRD (ENC452212/10086764) DEPLOYED AND GOT LOST IN THE SHAFT OF THE HEADWAY MICROCATHETER AND COULDN'T BE PLACED IN THE CEREBRAL VESSEL. THE SECOND ENTERPRISE VRD (ENC452212/10086764) WAS FOUND IN THE Y-CONNECTOR. THE FIRST STENT WAS NOT ABLE TO BE REMOVED FROM THE HUB OF THE HEADWAY MICROCATHETER WITHOUT REQUIRING REMOVAL OF THE STENT AND HEADWAY MICROCATHETER TOGETHER AS A UNIT. THE HEADWAY MICROCATHETER WAS EXCHANGED FOR THE REBAR 27 OVER A GUIDEWIRE. AFTERWARDS, TWO MORE ENTERPRISE STENTS WERE PLACED THROUGH A REBAR 27 CATHETER WHICH WORKED VERY WELL. IT WAS REPORTED THAT IT SEEMS HAVE BEEN DUE TO THE HEADWAY CATHETER WHICH IS CLEARLY IS NOT INDICATED FOR USAGE WITH ENTERPRISE AS WELL AS REBAR 27. ONE NON-STERILE ENTERPRISE VRD DELIVERY WIRE AND INTRODUCER WERE RECEIVED COILED INSIDE A PLASTIC BAG THE ORIGINAL OUTER BOX WAS ALSO RECEIVED. IT WAS REPORTED THAT IT IS NOT KNOW IF THIS WAS THE DELIVERY WIRE FROM THE FIRST OR SECOND STENT THAT WAS ATTEMPTED TO BE INSERTED INTO THE MICROCATHETER. THE SAMPLE WAS INSPECTED AND RESIDUES OF DRIED BLOOD WERE FOUND INSIDE INTRODUCER TUBE. NO OTHER ISSUES WERE FOUND. THE STENT AND COIL DISPENSER WERE NOT RECEIVED. THE DELIVERY WIRE COIL TIP AND INTRODUCER TUBE WERE OBSERVED UNDER MICROSCOPE MAGNIFICATION AND NO ANOMALIES/DAMAGES WERE NOTED, ONLY RESIDUES OF DRIED BLOOD. FUNCTIONAL ANALYSIS WAS PERFORMED WITH THE DELIVERY WIRE WITHOUT THE STENT, WHICH WAS NOT RECEIVED. THE DELIVERY WIRE WAS INTRODUCED AND ADVANCE THROUGH MICROCATHETER WITHOUT ANY PROBLEMS. INTRODUCER TUBE DISTAL END SEATED CORRECTLY ON MICROCATHETER HUB. NOTE: A LAB SAMPLE MICROCATHETER WAS USED FOR THIS TESTING SINCE THE INVOLVED MICROCATHETER WAS NOT RETURNED FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10086764. 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 PREMATURE DEPLOYMENT OF THE STENTS COULD NOT BE EVALUATED SINCE THE STENTS WERE NOT RECEIVED. HOWEVER NO ANOMALIES WERE NOTED DURING FUNCTIONAL ANALYSIS WITH THE DELIVERY WIRE AND THE DISTAL END OF THE INTRODUCER TUBE SEATED CORRECTLY IN THE LAB SAMPLE MICROCATHETER HUB. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES BASED ON THE ANALYSIS OF THE RETURNED COMPONENTS OR THE DEVICE HISTORY RECORDS REVIEW. THERE WERE NO DEFECTS OR ANOMALIES FOUND. THE INSTRUCTIONS FOR USE INDICATES THAT THE ENTERPRISE VRD IS DESIGNED FOR USE UNDER FLUOROSCOPY WITH THE PROWLER SELECT PLUS INFUSION CATHETER, A 0.021¿ INNER DIAMETER, 5 CM DISTAL LENGTH INFUSION CATHETER. AS REPORTED THE PROCEDURAL FACTOR OF USE WITH AN INCOMPATIBLE DELIVERY CATHETER (ID GREATER THAN SPECIFIED) APPEARS TO HAVE CONTRIBUTED TO THE EVENT. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE FIRST ENTERPRISE VRD AND DELIVERY (ENC452212/10086764) DEPLOYED AND GOT LOST IN THE SHAFT OF THE HEADWAY MICROCATHETER AND COULDN'T BE PLACED IN THE CEREBRAL VESSEL AND THE SECOND ENTERPRISE VRD AND DELIVERY (ENC452212/10086764) WAS FOUND IN THE Y-CONNECTOR. THE FIRST STENT WAS NOT ABLE TO BE REMOVED FROM THE HUB OF THE HEADWAY MICROCATHETER WITHOUT REQUIRING REMOVAL OF THE STENT AND HEADWAY MICROCATHETER TOGETHER AS A UNIT. THE HEADWAY MICROCATHETER WAS EXCHANGED FOR THE REBAR 27 OVER A GUIDEWIRE. AFTERWARDS, TWO MORE ENTERPRISE STENTS WERE PLACED THROUGH A REBAR 27 CATHETER WHICH WORKED VERY WELL. IT SEEMS TO BE THE HEADWAY CATHETER WHICH IS CLEARLY NOT INDICATED FOR USAGE WITH ENTERPRISE AS WELL AS REBAR 27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262510 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10086764

    Patients

    Seq Age Sex Outcome Treatment
    1