BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCS COMPLEX FILL 9 X 25

    MDR report key: 1032589 · Received April 21, 2008

    Report

    Report Number
    1058196-2008-00104
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K014041
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REMOVAL FROM THE PACKAGE, THE COIL WAS REMOVED ACCORDING TO (IFU) INSTRUCTION FOR USE GUIDELINES. THE COIL WAS NOT MANIPULATED IN ANY WAY, AND THE COIL WAS ONLY INSPECTED PRIOR TO PREP. THE ZIPPER WAS LOCK IN POSITION. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING PREP, THE PHYSICIAN FOUND THAT THE COIL WAS UNRAVELED. THIS UNRAVEL WAS NOTICED WHEN THE PHYSICIAN TOOK THE PRODUCT OUT OF THE PACKAGE, AND INSPECTED ACCORDING TO (IFU) INSTRUCTION FOR USE. THE PRODUCT WAS NOT CLINICALLY USED, BUT ANOTHER COIL (CAT/LOT UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCS COMPLEX FILL 9 X 25 CNV DCS COILS (HCG) HCG CORDIS NEUROVASCULAR, INC. NA I3096927

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK