BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2972269 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00945
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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 MFR: KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AT 27.3CM AND 34.5CM FROM FEMORAL MARKER AT THE DISTAL END. 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. ONE HUB WING WAS BENT WHEN THE DEVICE WAS RECEIVED. 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 MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION DIAGNOSTIC PROCEDURE, THE GUIDE WIRE EXIT PORT WAS STUCK IN THE STENT. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO ISSUE DURING THE PRE-IVUS. NEXT, THEY IMPLANTED A NON-BSC STENT TO TREAT THE STENOSIS. AN F/G ATLANTIS SR PRO WAS USED TO VISUALIZE THE LESION. THEY PERFORMED THE POST-IVUS AND TRIED TO REMOVE THIS DEVICE FROM THE LESION. THE GUIDE WIRE EXIT PORT OF THIS DEVICE WAS STUCK WITH THE DISTAL EDGE OF THE STENT. THE PHYSICIAN ROTATED THE CATHETER AND MANAGED TO REMOVE THE CATHETER FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS POST PROCEDURE WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION DIAGNOSTIC PROCEDURE, THE GUIDE WIRE EXIT PORT WAS STUCK IN THE STENT. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A NON-BSC BALLOON CATHETER WAS USED FOR PRE-DILATATION. THE PHYSICIAN IMPLANTED A NON-BSC STENT TO TREAT THE STENOSIS. AN ATLANTIS SR PRO WAS USED TO VISUALIZE THE LESION. THEY PERFORMED THE POST-IVUS AND TRIED TO REMOVE THIS DEVICE FROM THE LESION. THE PHYSICIAN THOUGHT THAT THE WIRE WAS SEPARATED DUE TO THE SHORT MONORAIL, THE STENT STRUT WAS STUCK WITH THE EXIT PORT. THE PHYSICIAN ROTATED THE CATHETER AND MANAGED TO REMOVE THE CATHETER FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS POST PROCEDURE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76935 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15598363

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE PRIME 3.0×15MM