BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO

    MDR report key: 3881344 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03326
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    February 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE SHEATH WAS MISSING WHEN THE DEVICE WAS RECEIVED. IMPEDANCE TESTING FINDS THE DEVICE IS CAPABLE OF IMAGING PROPERLY. 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 WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE IMAGE DID NOT APPEAR. THE ATLANTIS SR PRO IMAGING CATHETER USED TO VISUALIZED 75% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. IT WAS NOTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE IMAGE DID NOT APPEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS NORMAL. HOWEVER, THE SHEATH WAS MISSING WHEN THE DEVICE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357027 ATLANTIS? SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749389420 16016585

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR