BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3253917 · Received July 30, 2013

    Report

    Report Number
    2134265-2013-05198
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 MDR ID 2134265-2013-05196 AND 2134265-2013-05197. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 75% STENOSED AND MILDLY CALCIFIED LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH ATLANTIS SR PRO2 INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK BECAUSE THE CLUTCH LEVER WAS DISABLED. AUTOMATIC PULLBACK WAS ATTEMPTED 2 TO 3 TIMES AND THEY PERFORMED MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355423 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140

    Patients

    Seq Age Sex Outcome Treatment
    1