BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1526335 · Received October 27, 2009

    Report

    Report Number
    2939204-2009-00803
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Report Date
    October 9, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) : K931584, K944677, K971254, K964611 AND K022357. DEVICE MFR DATE: UNK. THIS REPORT IS RELATED TO MANUFACTURE REPORT 2939204-2009-001.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH THE STENT DELIVERY SYSTEM AND WAS FOUND TO HAVE SEPARATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NEUROFORM 3 STENT DELIVERY SYSTEM| (BOSTON SCIENTIFIC)