BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA-21 MICROCATHETER

    MDR report key: 10694461 · Received October 16, 2020

    Report

    Report Number
    2032493-2020-00290
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 16, 2020
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    DQY
    PMA / PMN Number
    K150894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AND PROCEDURE IMAGES WERE NOT PROVIDED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ANEURYSM RUPTURE AND VESSEL PERFORATION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ACOM ANEURYSM. DURING ADVANCEMENT OF THE WEB THROUGH THE VIA IN TORTUOUS ANATOMY, THE VIA UNEXPECTEDLY MOVED FORWARD AND THE ANEURYSM WAS PERFORATED. THE WEB WAS QUICKLY DEPLOYED, AS WAS INTENDED, IN THE ANEURYSM AND BLEEDING SUBSIDED. THE PATIENT IS REPORTED TO BE STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155843 VIA-21 MICROCATHETER PERCUTANEOUS CATHETER DQY SEQUENT MEDICAL, INC VIA-21-154-01-MVI2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening