BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE (TM) PT

    MDR report key: 2202661 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03220
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS 2134265-2011-03439. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE THE GUIDE WIRE BROKE. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THEY WERE UNABLE TO EXCHANGE THE CHOICE PT GUIDE WIRE THROUGH THE APEX 2.0X15MM BALLOON AS COATING MATERIAL WAS BLOCKING THE SHAFT OF CATHETER OF THE MANIFOLD. THE CHOICE PT GUIDE WIRE BROKE OFF IN AN EFFORT TO ADVANCE THROUGH THE BALLOON. AT THIS POINT THE BALLOON AND WIRE WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE (TM) PT WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491216001J1

    Patients

    Seq Age Sex Outcome Treatment
    1 APEX BALLOON