BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2153718 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02513
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 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: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE TWO FLAPS OF HUB ROTATOR WERE DAMAGED. HOWEVER, THE UNIT WAS ABLE TO CONNECT INTO MDU SYSTEM PROPERLY. THE GUIDEWIRE EXIT PORT WAS LIFTED 0.5 MM. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE 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. 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 STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOLATERAL BRANCH. A PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED. POST-IVUS WAS PERFORMED WITH AN ATLANTIS SR PRO IMAGING CATHETER DURING WHICH THE IMAGING CATHETER GOT STUCK IN THE STENT. THE NON-BSC GUIDE WIRE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO WITHDRAW THE ATLANTIS IMAGING CATHETER BUT THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER GOT STUCK ON THE STENT. AFTER DEEP SEATING THE CATHETER, THEY WERE ABLE TO REMOVE THE DEVICE. BALLOON ANGIOPLASTY WAS USED TO POST DILATE THE PROMUS STENT AND ADDITIONAL IVUS WAS PERFORMED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOLATERAL BRANCH. A PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED. POST-IVUS WAS PERFORMED WITH AN ATLANTIS SR PRO IMAGING CATHETER DURING WHICH THE IMAGING CATHETER GOT STUCK IN THE STENT. THE NON-BSC GUIDE WIRE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO WITHDRAW THE ATLANTIS IMAGING CATHETER BUT THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER GOT STUCK ON THE STENT. AFTER DEEP SEATING THE CATHETER, THEY WERE ABLE TO REMOVE THE DEVICE. BALLOON ANGIOPLASTY WAS USED TO POST DILATE THE PROMUS STENT AND ADDITIONAL IVUS WAS PERFORMED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749390140 14221057

    Patients

    Seq Age Sex Outcome Treatment
    1 RUNTHROUGH NS GUIDE WIRE| PROMUS STENT