BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2221218 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03804
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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

    DEVICE EVALUATED BY MFR.: EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS NO DAMAGE ON THE DISTAL TIP OR GUIDEWIRE EXIT PORT ASSEMBLY AND THERE WAS NO ELONGATION OR STRETCH IN THE DISTAL TIP ASSEMBLY. A 0.014- TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. DURING IMAGE CHARACTERIZATION TESTING, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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. ALTHOUGH NO DAMAGE WAS FOUND AND THE UNIT WAS ABLE TO FUNCTION PROPERLY, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN IMAGING CATHETER BECAME CAUGHT ON THE PLACED STENT. THE 75% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A CYPHER STENT WAS PREVIOUSLY IMPLANTED IN MIDDLE LAD. THIS PCI WAS PERFORMED FOR A DE NOVO LESION IN DISTAL PORTION OF THE CYPHER IMPLANTED LOCATION. AN ATLANTIS SR PRO2 INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED WITH NO PROBLEM DURING PRE-IVUS. THE LESION WAS PRE-DILATED WITH A 2.0MM BALLOON AND THEN A 2.5MM NOBORI STENT WAS IMPLANTED. RESISTANCE WAS NOTED WHILE ADVANCING THE IVUS CATHETER DURING POST-IVUS. THE DISTAL PORTION OF THE IVUS CATHETER BECAME CAUGHT ON THE CYPHER STENT AND THEN THE IMAGE WAS LOST. THE PHYSICIAN PULLED ON THE IVUS CATHETER AND IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. ACCORDING TO THE PHYSICIAN, THE DISTAL PORTION OF THE IVUS CATHETER MIGHT HAVE BECOME ELONGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN IMAGING CATHETER BECAME CAUGHT ON THE PLACED STENT. THE 75% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A CYPHER STENT WAS PREVIOUSLY IMPLANTED IN MIDDLE LAD. THIS PCI WAS PERFORMED FOR A DE NOVO LESION IN DISTAL PORTION OF THE CYPHER IMPLANTED LOCATION. AN ATLANTIS SR PRO2 INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED WITH NO PROBLEM DURING PRE-IVUS. THE LESION WAS PRE-DILATED WITH A 2.0MM BALLOON AND THEN A 2.5MM NOBORI STENT WAS IMPLANTED. RESISTANCE WAS NOTED WHILE ADVANCING THE IVUS CATHETER DURING POST-IVUS. THE DISTAL PORTION OF THE IVUS CATHETER BECAME CAUGHT ON THE CYPHER STENT AND THEN THE IMAGE WAS LOST. THE PHYSICIAN PULLED ON THE IVUS CATHETER AND IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. ACCORDING TO THE PHYSICIAN, THE DISTAL PORTION OF THE IVUS CATHETER MIGHT HAVE BECOME ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749390140 14301951

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 6FR LAUNCHER