BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 3023882 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01951
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER 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 MDR ID # 2134265-2013-01950, 2134265-2013-01952. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION THE MOTOR DRIVE FAILED TO PULLBACK. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN ATLANTIS SR PRO² INTRAVASCULAR CATHETER WAS USED TO DIAGNOSE THE LESION. DURING THE PROCEDURE, AUTOPULLBACK WAS FUNCTIONING WELL THEN SUDDENLY STOPPED. AFTER REBOOT, A CONNECTION ERROR OCCURRED. AFTER REBOOTING SEVERAL TIMES, THE SYSTEM AND THE MDU WERE ABLE TO FUNCTION WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATION REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125121 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140

    Patients

    Seq Age Sex Outcome Treatment
    1