BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3053140 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02295
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 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: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE GUIDEWIRE THAT WAS USED DURING PROCEDURE WAS NOT RETURNED. THE IMAGING CORE, TELESCOPE, AND HUB ASSEMBLY WERE MISSING; ONLY THE SHEATH ASSEMBLY WAS RECEIVED. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0MM. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. 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 OF OPERATIONAL CONTEXT WAS ASSIGNED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE AN IMAGING CATHETER STUCK ON THE STENT. THE 90% STENOSED AND MODERATELY CALCIFIED LESION WITH MODERATE TORTUOSITY WAS LOCATED PROXIMAL TO MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A NON-BSC STENT WAS IMPLANTED. THE PHYSICIAN PERFORMED IVUS FOLLOWING STENT DEPLOYMENT. DURING MANUAL PULLBACK, THE ATLANTIS SR PRO IMAGING CATHETER GOT STUCK ON THE EDGE OF THE NON-BSC STENT THAT WAS IMPLANTED. THEY ATTEMPTED TO REMOVE THE IMAGING CATHETER BY CUTTING THE PART OF THE HUB AND REMOVED ITS IMAGING CORE, THEN ADVANCED THE 0.14 INCH UNKNOWN GUIDE WIRE AND REMOVED THE IMAGING CATHETER FROM THE STENT. THEY COMPLETED THE PROCEDURE WITH THE BALLOON DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE AN IMAGING CATHETER STUCK ON THE STENT. THE 90% STENOSED AND MODERATELY CALCIFIED LESION WITH MODERATE TORTUOSITY WAS LOCATED PROXIMAL TO MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A NON-BSC STENT WAS IMPLANTED. THE PHYSICIAN PERFORMED IVUS FOLLOWING STENT DEPLOYMENT. DURING MANUAL PULLBACK, THE ATLANTIS SR PRO IMAGING CATHETER GOT STUCK ON THE EDGE OF THE NON-BSC STENT THAT WAS IMPLANTED. THEY ATTEMPTED TO REMOVE THE IMAGING CATHETER BY CUTTING THE PART OF THE HUB AND REMOVED ITS IMAGING CORE, THEN ADVANCED THE 0.14 INCH UNKNOWN GUIDE WIRE AND REMOVED THE IMAGING CATHETER FROM THE STENT. THEY COMPLETED THE PROCEDURE WITH THE BALLOON DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155184 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15742154

    Patients

    Seq Age Sex Outcome Treatment
    1 RESOLUTE INTEGRITY STENT