BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

    MDR report key: 10411605 · Received August 14, 2020

    Report

    Report Number
    2032493-2020-00206
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    DQY
    UDI-DI
    00851566003918
    PMA / PMN Number
    K150894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RUPTURED PERICALLOSAL ARTERY BIFURCATION ANEURYSM. THE VIA WAS TRACKED THROUGH A VESSEL THAT WAS REPORTED TO HAVE A 90-DEGREE ANGLE COURSING A SHORT A1 SEGMENT TO GET TO THE NECK OF THE ANEURYSM. THE FIRST WEB SELECTED FOR THE ANEURYSM WAS TOO LARGE, SO IT WAS REMOVED THROUGH THE VIA WITHOUT INCIDENT; HOWEVER, THE VIA WAS NOT IN THE PROPER LOCATION FOR PLACEMENT OF THE SMALLER WEB AND NEEDED TO BE TRACKED BACK UP. AFTER SUCCESSFUL DEPLOYMENT OF THE WEB IN THE ANEURYSM, A SLIGHT "DISSECTION" WAS NOTED IN SUBSEQUENT ANGIOGRAMS AT THE LOCATION OF THE 90-DEGREE ANGLE IN THE VESSEL. AFTER WAITING APPROXIMATELY FIVE (5) MINUTES, ADDITIONAL ANGIOGRAMS WERE TAKEN AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871994 VIA-21 MICROCATHETER-US VIA-21-154-01FOR US PERCUTANEOUS CATHETER DQY SEQUENT MEDICAL, INC FGA21154-01 19092326 00851566003918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other