BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3172944 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-03992
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 19, 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

    AGE AT TIME OF EVENT: 18 YEARS AND OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER:THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHEATH ASSEMBLY WAS MISSING WHEN RECEIVED. THE MALE/FEMALE LUER CONNECTION WAS DISCONNECTED AND THE IMAGING CORE WAS OUTSIDE OF THE SHEATH ASSEMBLY WHEN RECEIVED. THE SHEATH ASSEMBLY WAS MISSING AND NOT RETURNED BACK. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING VISUAL ANALYSIS. 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 DESIGN. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION THE CATHETER GOT STUCK WITH AN UNKNOWN DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN ATLANTIS SR PRO2 CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION. UPON TESTING THE DEVICE PRIOR TO USE THERE WERE NO ISSUE REPORTED, HOWEVER UPON ADVANCING THE DEVICE TO THE TARGET LESION THE IMAGE DID NOT APPEARED AND DURING THE PROCEDURE THE PHYSICIAN FOUND OUT THAT THE CATHETER GOT STUCK WITH AN UNKNOWN DEVICE. THEY REMOVE THE CATHETER FROM THE PATIENT AND FLUSH IT AGAIN BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273615 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15805945

    Patients

    Seq Age Sex Outcome Treatment
    1