BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2202826 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03224
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    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 EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITHOUT THE GUIDE WIRE USED IN THE PROCEDURE. THE GUIDE WIRE EXIT PORT WAS LIFTED 0.5MM. A TEST GUIDE WIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE TRACKING THE GUIDE WIRE INTO THE CATHETER WAS NOTED. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL. NO MANUFACTURING DEFECTS WERE OBSERVED DURING VISUAL AND MICROSCOPIC INSPECTION OF THE TRANSDUCER, DISTAL HOUSING, OR DISTAL END OF THE DRIVE CABLE. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING VISUAL AND FUNCTIONAL 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, DEVICE RETURNED TO MANUFACTURER: IT WAS ORIGINALLY REPORTED THAT THE DEVICE HAD BEEN RECEIVED FOR ANALYSIS AND EVALUATION WAS ANTICIPATED, BUT NOT YET BEGUN. HOWEVER, THE CORRECTED INFORMATION IS THAT THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A CATHETER BECAME STUCK WITH AN IMPLANTED STENT. THE TARGET LESION HAD SEVERE CALCIFICATION AND WAS TREATED WITH AN UNKNOWN STENT. THE PHYSICIAN USED THIS ATLANTIS SR PRO² INTRAVASCULAR ULTRASOUND (IVUS) DIAGNOSTIC CATHETER TO PERFORM POST STENT DEPLOYMENT IMAGING. DURING USE, THE GUIDE WIRE EXIT PORT OF THE CATHETER "CAUGHT" ON THE IMPLANTED STENT. THE PHYSICIAN ADVANCED THE IVUS CATHETER FORWARD, TURNED THE CATHETER, RELEASING THE CATHETER FROM THE STENT. THE DIAGNOSIS WAS COMPLETED WITH ANOTHER ATLANTIS SR PRO² IVUS CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A CATHETER BECAME STUCK WITH AN IMPLANTED STENT. THE TARGET LESION HAD SEVERE CALCIFICATION AND WAS TREATED WITH AN UNKNOWN STENT. THE PHYSICIAN USED THIS ATLANTIS SR PRO² INTRAVASCULAR ULTRASOUND (IVUS) DIAGNOSTIC CATHETER TO PERFORM POST STENT DEPLOYMENT IMAGING. DURING USE, THE GUIDE WIRE EXIT PORT OF THE CATHETER "CAUGHT" ON THE IMPLANTED STENT. THE PHYSICIAN ADVANCED THE IVUS CATHETER FORWARD, TURNED THE CATHETER, RELEASING THE CATHETER FROM THE STENT. THE DIAGNOSIS WAS COMPLETED WITH ANOTHER ATLANTIS SR PRO² IVUS CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A CATHETER BECAME STUCK WITH AN IMPLANTED STENT. THE TARGET LESION HAD SEVERE CALCIFICATION AND WAS TREATED WITH AN UNKNOWN STENT. THE PHYSICIAN USED THIS ATLANTIS SR PRO 2 INTRAVASCULAR ULTRASOUND (IVUS) DIAGNOSTIC CATHETER TO PERFORM POST STENT DEPLOYMENT IMAGING. DURING USE, THE GUIDE WIRE EXIT PORT OF THE CATHETER "CAUGHT" ON THE IMPLANTED STENT. THE PHYSICIAN ADVANCED THE IVUS CATHETER FORWARD, TURNED THE CATHETER, RELEASING THE CATHETER FROM THE STENT. THE DIAGNOSIS WAS COMPLETED WITH ANOTHER ATLANTIS SR PRO 2 IVUS CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749390140 14294043

    Patients

    Seq Age Sex Outcome Treatment
    1 0.014" GUIDE WIRE