BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 4221707 · Received November 3, 2014

    Report

    Report Number
    2134265-2014-06800
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 2134265-2014-06713 AND 2134265-2014-06801. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT FAILED TO DO AUTOMATIC PULLBACK. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703219 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1