BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSITC GUIDEWIRES

    MDR report key: 1476521 · Received July 7, 2009

    Report

    Report Number
    1016427-2009-00170
    Event Type
    Malfunction
    Date Received
    July 7, 2009
    Date of Event
    June 10, 2009
    Report Date
    June 10, 2009
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PRODUCT (CRA/CRB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE TIP OF THE WIRE WAS BROKEN ALREADY INSIDE THE PACKAGE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERALD DIAGNOSITC GUIDEWIRES CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK