BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2872309 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-08256
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 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). DEVICE EVALUATED BY MFR:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2012-08212. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE AUTOMATIC PULL BACK STOPPED. THE 75%-90% DIFFUSED LONG STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING AN AUTO PULLBACK OF ILAB MOTORDRIVE FOR PRE IMAGING (RUN 1) THERE WAS NOISE AND THE PULLBACK STOPPED. IMAGES WERE AVAILABLE ON THE SECOND AND THIRD RUNS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 F/G ASSY SLED PULLBACK SINGLE PACK MD5| WIRE: BMW UNIVERSAL, 2GC: (B)(4)| PROMUS ELEMENT 2.5/16 MM, PROMUS ELEMENT 3.0/16 MM| ILAB CART SYSTEM 100V MOTOR DRIVE UNT| JOKER TENKU 2.5/15 MM LAD PRE