BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA 27 MICROCATHETER

    MDR report key: 5974008 · Received September 23, 2016

    Report

    Report Number
    3008423090-2016-00009
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 3, 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 W4-5-S WAS TOO SMALL FOR THE ANEURYSM. UPON THE ATTEMPT TO -RE-SHEATH THE WEB INTO THE CATHETER IT WAS STUCK IN THE VIA 27 AND COULD NOT BE RE-SHEATHED. THE PHYSICIAN REMOVED BOTH THE WEB AND THE VIA 27 FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624924 VIA 27 MICROCATHETER CONTINUOUS FLUSH CATHETER KRA SEQUENT MEDICAL INC. VIA-27-154-01 15102107

    Patients

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