BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2920840 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00438
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 20, 2012
    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). 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 # 2134265-2013-00439, 2134265-2013-00440. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE AUTOMATIC PULL BACK WAS UNABLE TO BE PERFORMED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS OBTUS MARGINAL ARTERY. THE VASCULAR ACCESS WAS PERFORMED VIA FEMORAL ARTERY. THE AUTOMATIC PULLBACK OF THE MOTOR DRIVE OF THE ILAB SYSTEM WAS NOT ABLE TO BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25848 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15588117

    Patients

    Seq Age Sex Outcome Treatment
    1 F/G ASSY SLED PULLBACK SINGLE PACK MD5| MOTOR DRIVE UNIT, ILAB SYSTEM