BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4143617 · Received October 6, 2014

    Report

    Report Number
    1058196-2014-00249
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 29, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT AGE, GENDER, AND MEDICAL HISTORY WERE NOT PROVIDED. SINCE THE LOT NUMBERS WERE NOT PROVIDED, THE MANUFACTURE AND EXPIRATION DATES OF THE DEVICE IS UNKNOWN. COMPLAINT CONCLUSION: THE DEVICES WERE DISCARDED, AND NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT AVAILABLE, SO A REVIEW OF MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE RESISTANCE BETWEEN THE ENTERPRISE STENTS AND THE MICROCATHETER COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. BASED ON THE INFORMATION PROVIDED, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS THE ENTERPRISE INSTRUCTIONS FOR USE (IFU) DIRECTIONS FOR USE, ¿MAINTAIN FLUSH THROUGH ALL INFUSION CATHETERS PER STANDARD ENDOVASCULAR PRACTICE¿. THERE IS NO INDICATION, BASED ON THE INFORMATION RECEIVED, THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 3 MDRS RELATED TO THIS COMPLAINT FOR PATIENT (B)(6). THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RESISTANCE/FRICTION WHEN TRACKING 2 ENTERPRISE STENTS (ENF451412 AND ENF452200 LOTS UNKNOWN) THROUGH THE SHAFT OF THE PROWLER SELECT PLUS MICROCATHETER (60652S5JX). THE MICROCATHETER WAS REMOVED. THERE MAY NOT HAVE BEEN ADEQUATE FLUSH THROUGH THE MICROCATHETER PRIOR TO INSERTING THE ENTERPRISE DEVICES. THE PATIENT HAD NO COMPLICATIONS DUE TO THIS ISSUE. THE DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624909 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC ENF451412 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS MICROCATHETER