BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2962582 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-01022
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 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

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED TWO FLAPS OF HUB ROTATOR WERE DAMAGED, THE CROSS-SECTION OF THE HUB O-RING WAS MEASURED AND FOUND TO BE WITHIN PRODUCT SPECIFICATION. A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AT 19.8 CM FROM FEMORAL MARKER AT THE PROXIMAL END. NO ERROR MESSAGE WAS OBSERVED DURING FUNCTIONAL TESTING. THE TELESCOPE ASSEMBLY WAS ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LESION WAS MODERATELY CALCIFIED. MANUAL PULLBACK WAS NOT ATTEMPTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-01024 AND 2134265-2013-01023. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CATHETER WAS UNABLE TO PULL PACK. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING . A F/G ATLANTIS SR PRO² WAS USED FOR VISUALIZATION OF THE LESION. THE CONNECTION OF THE CATHETER WAS UNSTABLE, ERROR MESSAGE WAS APPEARED AS THE UNCONNECTED AND CONNECTED CATHETER CROSSED THE LESION, THEN UNABLE TO PULLBACK WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER F/G ATLANTIS SR PRO². THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65895 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15603619

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR