BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1230411 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04265
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT 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 THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED CORONARY PROCEDURE, THE GUIDE WIRE FRACTURED. A PT2 GUIDE WIRE HAD BEEN ADVANCED TO THE OBTUSE MARGINAL ARTERY. DURING THE PROCEDURE, THE GUIDE WIRE FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITH UNSPECIFIED MEANS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE DQX WIRE, GUIDE CATHETER DQX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR