BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX GUIDEWIRE, PLUS GUIDEWIRE

    MDR report key: 2010454 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00689
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A VESSEL PERFORATION OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. DURING THE MIDDLE OF THE PROCEDURE, A VESSEL PERFORATION OCCURRED WHILE UTILIZING AN UNSPECIFIED KINETIX GUIDE WIRE. IT WAS FURTHER NOTED THAT THE PATIENT 'DID NOT DO WELL.'

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PERFORATION WAS ABLE TO BE REPAIRED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX GUIDEWIRE, PLUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE UNK575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other