BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5973985 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00005
    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 PHYSICIAN WAS ATTEMPTING TO IMPLANT A WEB W2-8-5 INTO THE PATIENT'S ANEURYSM AND DECIDED IT WAS TOO LARGE BECAUSE IT PROTRUDED INTO THE PARENT VESSEL. THE PHYSICIAN ATTEMPTED WITH CONSIDERABLE FORCE TO RE-SHEATH THE WEB BUT IT WAS NOT RETRIEVABLE INTO THE VIA 27 CATHETER SO THE PHYSICIAN DECIDED TO PULL THE VIA 27 AND THE PARTIALLY RE-SHEATHED WEB OUT THROUGH THE NAVIEN CATHETER. AFTER BOTH WERE WITHDRAWN IT WAS OBSERVED THAT THE VIA 27 WAS DAMAGED, THE VIA AND WEB WERE "JAMMED" STUCK TOGETHER. THE PHYSICIAN USED A DIFFERENT VIA 27 AND IMPLANTED A SMALLER WEB 8-4. THERE WAS NO ISSUES WITH THE W 8-4 IMPLANT PROCEDURE AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625314 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 15012001

    Patients

    Seq Age Sex Outcome Treatment
    1 NAVIEN CATHETER| W2-8-5| WDC