BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 2983409 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01578
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K964611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHUN HO YU, SIMON. ET AL.(2011) ANGIOPLASTY AND STENTING OF ATHEROSCLEROTIC MIDDLE CEREBRAL ARTERIES WITH WINGSPAN: EVALUATION OF CLINICAL OUTCOME, RESTENOSIS, AND PROCEDURE OUTCOME. AJNR AM J NEURORADIOL 32:753-58, 2011. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A MID CEREBRAL STENTING TREATMENT PROCEDURE AN ARTERIAL DISSECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85961 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK175

    Patients

    Seq Age Sex Outcome Treatment
    1