BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISTAL ACCESS CATHETER 070

    MDR report key: 2459063 · Received February 8, 2012

    Report

    Report Number
    2954917-2012-00002
    Event Type
    Death
    Date Received
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K110483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CONCENTRIC MEDICAL INC. EMPLOYEE BECAME AWARE OF THE FOLLOWING INCIDENT DURING THE STROKE CONFERENCE AT (B)(4). THE PHYSICIAN, DR. (B)(6), MENTIONED THE FOLLOWING INCIDENT. DURING A CASE THAT DR. (B)(6) PERFORMED, HYDROPHILIC COATING PARTICLES WERE FOUND IN DISTAL ANATOMY DURING AN AUTOPSY AFTER A PIPELINE FLOW-DIVERTING STENT WAS PLACED. A DAC 070, MANUFACTURED BY CONCENTRIC MEDICAL, WAS USED AND COULD HAVE BEEN A POTENTIAL SOURCE. A MARKSMAN CATHETER MANUFACTURED BY EV3 WAS ALSO USED DURING THE CASE. THIS IS THE ONLY AVAILABLE INFORMATION REGARDING THE CASE, THERE WERE NO OTHER DETAILS PROVIDED. THERE WAS NO EVIDENCE OF A CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL ACCESS CATHETER 070 CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death