BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1101951 · Received August 6, 2008

    Report

    Report Number
    1058196-2008-00193
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2008-00102.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRUFILL DCS SYRINGE II BROKE/STRIPPED AT THE LUER LOCK CONNECTION SITE AFTER SUCCESSFULLY DEPLOYING THE SIXTH COIL. NO FURTHER COILS WERE PLACED; THEREFORE, A NEW SYRINGE WAS NOT NEEDED. WITH ANALYSIS OF THE RETURNED SYRINGE, A BROKEN OFF HUB OF AN UNKNOWN TRUFILL DCS ORBIT COIL DELIVERY SYSTEM WAS FOUND CONNECTED TO THE SYRINGE LUER LOCK CONNECTION SITE. BASED ON THE ANALYSIS, AN UNKNOWN ORBIT HAS BEEN ADDED TO THE COMPLAINT FILE. DESPITE MULTIPLE INVESTIGATIVE ATTEMPTS, FURTHER PROCEDURAL INFORMATION HAS NOT BEEN OBTAINED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TRUFILL DCS SYRINGE II