BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2212748 · Received August 16, 2011

    Report

    Report Number
    1058196-2011-00415
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 5, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE AND DELIVERY WIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RECEIVED FOR ANALYSIS. THE INTRODUCER TUBE WAS RETURNED INSERTED ON THE DISTAL SECTION. THE DELIVERY WIRE PRESENTED NO DAMAGES. NO ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE FUNCTIONAL ANALYSIS WAS PERFORMED BY DELIVERING THE ENTERPRISE DELIVERY SYSTEM THROUGH THE RECEIVED /ASSOCIATED MICROCATHETER WITHOUT STENT AND NO RESISTANCE OR FRICTION WAS FELT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427243. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), 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 FAILURE REPORTER BY THE COSTUMER AS "DELIVERY WIRE/IMPEDED-IN MICROCATHETER" WAS NOT CONFIRMED SINCE THE FUNCTIONAL ANALYSIS WAS PERFORMED SUCCESSFULLY. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, THEREFORE NO ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00415 AND 1058196-2011-00416. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE STENT ((B)(4)) WAS BLOCKED IN THE SELECT PLUS 150/5 CM 45 SHAPE MICROCATHETER ((B)(4)). NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT AND A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, WERE ANY OTHER DAMAGES NOTICED ON ANY OF THE DEVICES (DELIVERY SYSTEM- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIP -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, STENT-FRACTURE, SEPARATED, UPLIFTED STENT STRUTS, KINK, BEND, ETC, AND THE STENT REMAINED ATTACHED TO THE DELIVERY SYSTEM. ONE NON STERILE ENTERPRISE AND DELIVERY WIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RECEIVED FOR ANALYSIS. THE INTRODUCER TUBE WAS RETURNED ON THE DISTAL SECTION OF THE DELIVERY WIRE. THE DELIVERY WIRE PRESENTED NO DAMAGES. NO ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE FUNCTIONAL ANALYSIS WAS PERFORMING USING THE DELIVERY WIRE. THE DELIVERY WIRE WITHOUT THE STENT, WHICH WAS NOT RETURNED, WAS ABLE TO PASS THROUGH THE RETURNED PROWLER SELECT PLUS MICROCATHETER WITHOUT RESISTANCE OR FRICTION. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427243. 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 INABILITY TO INSERT THE RETURNED ENTERPRISE DELIVERY WIRE THROUGH THE RETURNED MC WAS NOT CONFIRMED. FUNCTIONAL TESTING WITH THE RETURNED ENTERPRISE DELIVERY WIRE WAS SUCCESSFULLY AND THE DIMENSIONAL ANALYSIS FOUND THE MC MET ID SPECIFICATIONS. WITHOUT THE RETURN OF THE ENTERPRISE STENT, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE RETURNED DELIVERY WIRE DID NOT PRESENT WITH ANY DAMAGES AND NEITHER THE DHR OR PRODUCT ANALYSIS SUGGESTS IT WAS MANUFACTURING RELATED. THE ANALYSIS OF THE RETURNED CONCOMITANT DEVICES SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED WITH NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT DEVICES WITH THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00415 AND 1058196-2011-00416.

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00415 AND 1058196-2011-00416. 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

    THE ENTERPRISE STENT (ENF452812/01427243) WAS BLOCKED IN THE SELECT PLUS 150/5 CM 45 SHAPE MICROCATHETER (606S255FX/15173091). NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT AND A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, WERE ANY OTHER DAMAGES NOTICED ON ANY OF THE DEVICES (DELIVERY SYSTEM- FRACTURES, SEPARATED, KINKS, BENDS, ETC, DISTAL TIP -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, STENT-FRACTURE, SEPARATED, UPLIFTED STENT STRUTS, KINK, BEND, ETC.) AND THE STENT REMAINED ATTACHED TO THE DELIVERY SYSTEM.

    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 01427243

    Patients

    Seq Age Sex Outcome Treatment
    1 SELECT PLUS MICROCATHETER