BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION®

    MDR report key: 3052173 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02199
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    MTD
    PMA / PMN Number
    K983171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ATRIAL TACHYCARDIA INTERVENTION PROCEDURE, A STERILIZATION ISSUE OCCURRED. WHEN THE OUTER PACKAGING OF THE CONSTELLATION MAPPING CATHETER WAS OPENED, THE SEAL ON THE PLASTIC WRAPPING WAS OPENED SO THAT THE STERILIZATION FIELD WAS BROKEN AND THEY DIDN'T KNOW IF THEY HAD DONE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONSTELLATION MAPPING CATHETER. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154855 CONSTELLATION® CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY MTD BOSTON SCIENTIFIC - SAN JOSE M004US8031U0 15600136

    Patients

    Seq Age Sex Outcome Treatment
    1