BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3113679 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03387
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVAL. BY MFR: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION OF THE RETURNED DEVICE REVEALED A KINK IN THE SHEATH ASSEMBLY AND ONE OF THE HUB WING WAS BENT. THE HUB FLAPS APPEARED NORMAL AND A GOOD CLICK SOUND WAS HEARD DURING INSERTION INTO THE MDU SYSTEM. THE TELESCOPE ASSEMBLY WAS ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. BY USING A TEST PULLBACK SLED ASSEMBLY, THE CATHETER WAS ABLE TO PROPERLY PULL BACK MANUALLY AND AUTOMATICALLY. 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 ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03389 , MDR ID 2134265-2013-03390. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), FAILURE TO PULLBACK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN NON-CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. WHILE USING AN ILAB IMAGING SYSTEM AND ASSY SLED PULLBACK SINGLE PACK MD5, THE PHYSICIAN SELECTED AN ATLANTIS SR PRO² TO ADVANCE THROUGH THE TARGET LESION BUT UNABLE TO PERFORM AUTOMATIC PULLBACK. THEY TRIED TO RECONNECT THE CATHETER AND USE THE CLUTCH LEVER TO SLIDE BUT IT DID NOT SOLVE THE ISSUE. MANUAL PULLBACK WAS NOT ATTEMPTED. AFTER EXCHANGING THE IMAGING CATHETER WITH ANOTHER OF THE SAME DEVICE, AUTOMATIC PULLBACK WAS PERFORMED WITHOUT PROBLEM. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03389, MDR ID 2134265-2013-03390. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), FAILURE TO PULLBACK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN NON-CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. WHILE USING AN ILAB IMAGING SYSTEM AND ASSY SLED PULLBACK SINGLE PACK MD5, THE PHYSICIAN SELECTED AN ATLANTIS SR PRO² TO ADVANCE THROUGH THE TARGET LESION BUT UNABLE TO PERFORM AUTOMATIC PULLBACK. THEY TRIED TO RECONNECT THE CATHETER AND USE THE CLUTCH LEVER TO SLIDE BUT IT DID NOT SOLVE THE ISSUE. MANUAL PULLBACK WAS NOT ATTEMPTED. AFTER EXCHANGING THE IMAGING CATHETER WITH ANOTHER OF THE SAME DEVICE, AUTOMATIC PULLBACK WAS PERFORMED WITHOUT PROBLEM. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215558 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15824285

    Patients

    Seq Age Sex Outcome Treatment
    1