BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC18L

    MDR report key: 3467977 · Received November 13, 2013

    Report

    Report Number
    0002954917-2013-00153
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    February 4, 2013
    Report Date
    October 29, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQO
    PMA / PMN Number
    K072796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE ANALYSIS CANNOT 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. HOWEVER, VESSEL DISSECTION AND HEMORRHAGE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO RECANALIZE THE OCCLUDED RIGHT RIGHT MIDDLE CEREBRAL ARTERY (MCA) A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. THE PHYSICIAN BELIEVED THAT THE MICROCATHETER MAY HAVE PERFORATED THE VESSEL DURING ADVANCEMENT RESULTING IN THE SAH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO RECANALIZE THE OCCLUDED RIGHT MIDDLE CEREBRAL ARTERY (MCA) A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. THE PHYSICIAN BELIEVED THAT THE MICROCATHETER MAY HAVE PERFORATED THE VESSEL DURING ADVANCEMENT RESULTING IN THE SAH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586865 MC18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other CATHETER (PENUMBRA)| V2.0 SOFT (CONCENTRIC MEDICAL)