BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2121619 · Received June 13, 2011

    Report

    Report Number
    1058196-2011-00289
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00288T AND 1058196-2011-00289. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINTS RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE ENTERPRISE SES SYSTEM HAD DEPLOYMENT DIFFICULTY - DURING REMOVAL FROM THE HOOP AND THAT TWO ORBIT MINI COMPLEX FILL COILS WERE STRETCHED. THERE ARE NO PATIENTS, LESION OR PROCEDURAL DETAILS AVAILABLE TO DATE. THE ACCOUNT REPORTED THAT THE ENTERPRISE WAS PULLED OUT FROM THE INTRODUCER TUBE AND TWO COILS WERE STRETCHED DURING THE PROCEDURE. THERE WAS NO SERIOUS INJURY REPORTED WITH THE EVENT. THE COMPLAINT DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15183798 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE COMPLAINT DEVICES THIS INVESTIGATION IS LIMITED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE VERY LIMITED INFORMATION SUGGESTS THAT HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00288 AND 1058196-2011-00289.

    Description of Event or Problem · 1

    THE ENTERPRISE WAS PULLED OUT FROM THE INTRODUCER TUBE AND TWO COILS WERE STRETCHED DURING THE PROCEDURE. THERE WAS NO SERIOUS INJURY REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15183798

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER SL10 45