BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 4250751 · Received November 14, 2014

    Report

    Report Number
    1016427-2014-00117
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 20, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS RECEIVED VIA VOLUNTARY MEDWATCH #(B)(4) AND IS ATTACHED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA A VOLUNTARY MEDWATCH, DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DISTAL TIP OF THE SGW ATW .014 J FLOPPY 195CM GUIDEWIRE BECAME ENTRAPPED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. ADDITIONAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737781 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION 595MEJ014 F0913123

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R