BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5973977 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00003
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    July 8, 2015
    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

    Additional Manufacturer Narrative · 1

    NOTE: THE WEB (WEB ANEURYSM EMBOLIZATION SYSTEM) DEVICE MENTIONED IN THIS REPORT IS PART OF A (B)(6) STUDY UNDER (B)(6) AND HAS COMPLETED ENROLLMENT AS OF MARCH 2016. RECALL: 0000000-09/XX/2016-001-R. TO BE UPDATED WHEN THE REPORTING NUMBER HAS BEEN FINALIZED. DEVICE WAS DISCARDED AND NOT RETURNED.

    Description of Event or Problem · 1

    DURING THE WEB IMPLANT PROCEDURE IT WAS FOUND THAT THE FIRST WEB DEVICE W2-9-5 WAS OVERSIZED. THE PHYSICIAN WAS UNABLE TO RECAPTURE THE DEVICE THEREFORE THE MICROCATHETER AND DEVICE WERE REMOVED. A WEB SIZE W2-8-5 WAS IMPLANTED AND THERE WAS NO DEFICIT REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624845 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5F NAVIEN 058 - COVIDIEN| 6F SHUTTLE - COOK(2)| NEUROFORM EZ STENT| STENT 35X20 - STRYKER| TRANSEND 14EX - STRYKER| W2-9-5| WDC