BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5973997 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00008
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    July 6, 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 (B)(4) WAS RINSED AND INSERTED IN THE VIA 27 AND BROUGHT UP TO THE ANEURYSM. THE VIA 27 WAS NOT PRE-SHAPED OR OTHERWISE TREATED BEFORE USE. THE (B)(4) WAS DEPLOYED. PROF. (B)(6) WISHED TO REPOSITION THE DEVICE BUT COULD NOT RE-SHEATH IT ON THE FIRST ATTEMPT. ON THE SECOND ATTEMPT, BY AT THE SAME TIME PULLING THE VIA BACK AND USING THE ANATOMY TO DEFLATE THE WEB, HE COULD AT LEAST PARTIALLY (80%?) RE-SHEATH THE WEB BY USING SIGNIFICANT FORCE AND DECIDED TO EVACUATE BOTH THE WEB AND VIA THROUGH THE DISTAL ACCESS CATHETER. ON INSPECTION, THE VIA 27 DISTAL PART SHOWED SIGNIFICANT DEFORMATION. BOTH WEB AND VIA WHERE IMMEDIATELY PACKED UP IN A BAG NOT CHANGING THE POSITION THEY WERE EVACUATED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624922 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 16041501

    Patients

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