BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5974001 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00006
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SEQUENT MEDICAL INC.
    Product Code
    KRA
    PMA / PMN Number
    K132652
    Removal / Correction Number
    SEE BOX 10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE WEB WAS DEPLOYED INTO THE BT ANEURYSM. THE WEB TOO LARGE AND WEB RETRIEVAL WAS ATTEMPTED. WE WERE UNABLE TO FULLY RE-SHEATH THE WEB INSIDE THE VIA MICROCATHETER. THE WEB WAS STUCK AT THE DISTAL TIP OF THE VIA MICROCATHETER AFTER PARTIALLY RE-SHEATHING. BOTH THE WEB + VIA WERE RETRIEVED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625316 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 16041501

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)