BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2832616 · Received November 14, 2012

    Report

    Report Number
    1058196-2012-00415
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE STENT ((B)(4)) WOULD NOT DEPLOY OUT OF THE PROWLER SELECT PLUS ((B)(4)). IT WAS INDICATED THAT THERE WAS NO SERIOUS INJURY AS A RESULT OF THE EVENT AND NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS REQUIRED TO PREVENT IMPAIRMENT OR INJURY. NO FURTHER INFORMATION WAS OBTAINABLE WITH FOLLOW-UP INVESTIGATION. A NON-STERILE ENTERPRISE VRD AND DELIVERY WIRE SYSTEM INCLUDING THE DELIVERY WIRE, INTRODUCER AND STENT WERE RECEIVED COILED INSIDE OF A PLASTIC BAG. THERE WERE NO OBSERVED DAMAGES ON THE COMPONENTS. THE STENT WAS RECEIVED DEPLOYED. A NON-STERILE PROWLER SELECT PLUS 150/5 CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE MICROCATHETER WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE ID OF THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. FUNCTIONAL ANALYSIS WITH THE DELIVERY WIRE WITHOUT THE STENT, SINCE IT WAS DEPLOYED, WAS PERFORMED USING THE INVOLVED PROWLER SELECT PLUS MICROCATHETER. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT AND THE DELIVERY WIRE WAS ABLE TO BE ADVANCED ALL THE WAY THROUGH THE PROWLER SELECT PLUS. THE DELIVERY WIRE, INTRODUCER AND STENT WERE ALL OBSERVED UNDER THE VISION SYSTEM AND NO DAMAGES WERE FOUND. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT A 0.018 GUIDE WIRE CORDIS LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY THROUGH TO THE MICROCATHETER'S DISTAL END. AFTER THAT THE MICROCATHETER WAS FLUSHED AGAIN USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT AN ENTERPRISE LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP WITHOUT DIFFICULTY. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10141316. 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 (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. NOTE: THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00414 AND 1058196-2012-00415.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE PHYSICIAN STATED THAT THE ENTERPRISE STENT WOULD NOT DEPLOY OUT OF THE PROWLER SELECT PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10141316

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS MICROCATHETER: LOT 15691216