BEUDAMED
    FDA Adverse Event Death Summary report: N

    8F BGC 95CM

    MDR report key: 5336721 · Received December 30, 2015

    Report

    Report Number
    0002954917-2015-00171
    Event Type
    Death
    Date Received
    December 30, 2015
    Date of Event
    December 21, 2012
    Report Date
    December 7, 2015
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. VESSEL DISSECTION AND PATIENT DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS DETERMINED TO BE A DUPLICATE OF AN EARLIER COMPLAINT. MDR 0002954917-2013-00014 WAS FILED FOR THE EARLIER COMPLAINT. THEREFORE, A RETRACTION MDR IS BEING SUBMITTED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POST MARKET SURVEILLANCE REPORT THAT THE CLOT WAS LOCATED IN THE LEFT M2. DURING CLOT REMOVAL WITH THE SUBJECT DEVICE, THE PATIENT SUDDENLY GOT UP AND DUE TO THE MOTION, THE LEFT INTERNAL CAROTID ARTERY GOT DISSECTED. NO TREATMENT WAS ADMINISTERED AS THERE WERE NO CAROTID STENTS IN THE HOSPITAL. THE TICI SCORE WAS 1. THE PATIENT PASSED AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POST MARKET SURVEILLANCE REPORT THAT THE CLOT WAS LOCATED IN THE LEFT M2. DURING CLOT REMOVAL WITH THE SUBJECT DEVICE, THE PATIENT SUDDENLY GOT UP AND DUE TO THE MOTION, THE LEFT INTERNAL CAROTID ARTERY GOT DISSECTED. NO TREATMENT WAS ADMINISTERED AS THERE WERE NO CAROTID STENTS IN THE HOSPITAL. THE TICI SCORE WAS 1. THE PATIENT PASSED AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POST MARKET SURVEILLANCE REPORT THAT THE CLOT WAS LOCATED IN THE LEFT M2. DURING CLOT REMOVAL WITH THE SUBJECT DEVICE, THE PATIENT SUDDENLY GOT UP AND DUE TO THE MOTION, THE LEFT INTERNAL CAROTID ARTERY GOT DISSECTED. NO TREATMENT WAS ADMINISTERED AS THERE WERE NO CAROTID STENTS IN THE HOSPITAL. THE TICI SCORE WAS 1. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859797 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O