BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 2900250 · Received January 7, 2013

    Report

    Report Number
    2134265-2012-08344
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.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 MFR#: 2134265-2012-08345 AND 2134265-2012-08304.IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION THE MOTOR DRIVE WAS UNABLE TO PERFORM PULLBACK. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING (LAD). USING AN UNKNOWN BSC CATHETER, AUTOMATIC PULLBACK WAS ATTEMPTED MULTIPLE TIMES. THE MOTOR DRIVE WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. MANUAL PULLBACK WAS ATTEMPTED AND WAS NOT SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6024 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1