BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1497407 · Received September 4, 2009

    Report

    Report Number
    2939204-2009-00727
    Event Type
    Malfunction
    Date Received
    September 4, 2009
    Date of Event
    August 18, 2009
    Report Date
    August 25, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510 (K) #: K002907.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT FIRST GUIDEWIRE (SUBJECT DEVICE) COATING WAS FLAKING OFF. ANOTHER OF THE SAME GUIDEWIRE WAS USED AND HAD THE SAME PEELING PROBLEM. THE PROCEDURE WAS COMPLETED USING THE THIRD GUIDEWIRE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PT. THE PT WAS REPORTEDLY IN GOOD CONDITION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. M00313010 B17060

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNCHRO GUIDEWIRE (BOSTON SCIENTIFIC)