BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 14 GUIDEWIRE

    MDR report key: 1508264 · Received September 23, 2009

    Report

    Report Number
    2939204-2009-00752
    Event Type
    Malfunction
    Date Received
    September 23, 2009
    Date of Event
    June 29, 2009
    Report Date
    August 29, 2009
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE AND DEVICE MANUFACTURE DATE: UNKNOWN AS THE LOT NUMBER WAS NOT DISCLOSED. ADD'L PMA/510(K): K944677, K971254, K931584.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED IT HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX 14 GUIDEWIRE DQX BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 (BOSTON SCIENTIFIC)| NEUROFORM 3 STENT DELIVERY SYSTEM