BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 6311731 · Received February 8, 2017

    Report

    Report Number
    3008423090-2017-00001
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 11, 2017
    Report Date
    February 8, 2017
    Manufacturer
    SEQUENT MEDICAL INC
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN HAD CHOSEN TO WEB AN ELECTIVE UN-RUPTURED ICAT AND A SECOND PHYSICIAN WAS PROCTORING THE CASE. THE SECOND PHYSICIAN PHONED ME AFTER THE CASE AND EXPLAINED THAT ONCE THE WEB HAD BEEN PARTIALLY OPENED THEY DECIDED TO RE-SHEATH. WHEN THEY WERE RE-SHEATHING THE VIA MOVED FORWARDS AND WENT THROUGH THE WALL OF THE ANEURYSM. IT WAS A LARGE HOLE AND LED TO A SEVERE MAJOR BLEED. THEY THEN DECIDED TO REMOVE THE VIA AND WEB, PUT A BALLOON UP AND COIL THE ANEURYSM. THIS IS THE SAME EVENT AS (B)(4). THE PATIENT FROM WEDNESDAY IS RECOVERING SLOWLY. COILS WERE PLACED IN THE RUPTURED ANEURYSM TO STABILIZE IT. PATIENT SENT TO SURGERY TO RELEASE PRESSURE FROM THE BLEED. THE PATIENT REMAINS VERY POORLY AND THE HOSPITAL PHYSICIAN DOES NOT HOLD MUCH HOPE FOR A GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92622 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC VIA-27-154-01 16111706

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization (B)(4)