BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3103184 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03356
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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 MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED THE HUB FLAPS APPEARED NORMAL AND A GOOD CLICK SOUND WAS HEARD DURING INSERTION INTO THE MDU SYSTEM. THE CATHETER WAS ABLE TO PROPERLY PULL BACK MANUALLY AND AUTOMATICALLY. NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL DURING IMAGE CHARACTERIZATION TESTING. THE DEVICE FAILED TO MET SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT IS 18 YEARS OLD OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03179 AND 2134265-2013-03367. IT WAS REPORTED THAT WHILE IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 90% STENOSED AND CALCIFIED LESION WAS LOCATED AT THE PROXIMAL RIGHT CORONARY ARTERY, WITH SEVERE TORTUOSITY. THE ILAB INSTL SYSTEM 100V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT IN PREPARATION FOR THE PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK AND MISSING IMAGE OCCURED. AUTO PULLBACK WAS ATTEMPTED 5 TIMES AND THE PHYSICIAN PERFORMED MANUAL PULLBACK 3 TIMES. THEY REPLACED THE MOTOR DRIVE UNIT, CATHETER AND SLED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03179 AND 2134265-2013-03367. IT WAS REPORTED THAT WHILE IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 90% STENOSED AND CALCIFIED LESION WAS LOCATED AT THE PROXIMAL RIGHT CORONARY ARTERY, WITH SEVERE TORTUOSITY. THE ILAB INSTL SYSTEM 100V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT IN PREPARATION FOR THE PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK AND MISSING IMAGE OCCURRED. AUTO PULLBACK WAS ATTEMPTED 5 TIMES AND THE PHYSICIAN PERFORMED MANUAL PULLBACK 3 TIMES. THEY REPLACED THE MOTOR DRIVE UNIT, CATHETER AND SLED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203382 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15811252

    Patients

    Seq Age Sex Outcome Treatment
    1