BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA MICROCATHETER

    MDR report key: 3634847 · Received February 3, 2014

    Report

    Report Number
    3008423090-2014-00001
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    January 18, 2014
    Report Date
    February 4, 2014
    Manufacturer
    SEQUENT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K132652
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PHYSICIAN'S DESCRIPTION OF THE CASE, THE TIP OF THE VIA MICROCATHETER BECAME DEFORMED OR WAS TOO SOFT TO ADEQUATELY DELIVER THE EMBOLIZATION DEVICE. HOWEVER, IT APPEARS THE EMBOLIZATION DEVICE RE-RUPTURED THE ANEURYSM. BECAUSE THE VIA MICROCATHETER CONTRIBUTED TO THE EVENT, IT IS BEING REPORTED. THE WEB ANEURYSM EMBOLIZATION DEVICE IS NOT AVAILABLE FOR USE OR SALE IN THE UNITED STATES. THE PHYSICIAN INDICATED THE VIA MICROCATHETER TIP SOFTENED AND AS A RESULT PERFORATED THE ANEURYSM, HOWEVER, INITIAL INVESTIGATION RESULTS INDICATE THE PRODUCT MET THE SPECIFICATIONS. THERE HAVE BEEN APPROXIMATELY 500 CLINICAL USES OF THE VIA MICROCATHETER AND THIS IS THE FIRST REPORTED EVENT OF THIS TYPE, THEREFORE, OTHER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT (TIP PLACEMENT IN ANEURYSM, ANEURYSM CONDITION ETC.) THE INSTRUCTIONS FOR USE CLEARLY DEFINE THE POTENTIAL COMPLICATIONS, INCLUDING VESSEL PERFORATION, VESSEL OCCLUSION AND STROKE. WITHOUT THE ACTUAL DEVICE TO PERFORM AN INVESTIGATION, THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AND ADD'L TESTING ON A UNIT FROM THIS LOT IS PLANNED. THE FILE WILL BE UPDATED WHEN THE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PHYSICIAN DESCRIPTION: USED A 6X3 DUAL LAYER WEB IN A WIDE NECK ACOMM NECK OSTIUM (6X4 MM). DELIVERED IT ONE INTO THE ANEURYSM BUT THE MIDDLE AND DISTAL MARKERS WERE COMPRESSED AGAINST EACH OTHER. REMOVED IT AND IN SPITE OF GOOD COAXIAL GUIDING CATHETER FOUNDATION (NEURONMAX/NEURON) AND SHAPED VIA, I DID NOT HAVE ENOUGH CONTROL AT THE TIP OF THE DEVICE I.E. BEFORE IT SOFTENED, AND THE VIA/ DEVICE RUPTURED THE ANEURYSM. PATIENT HAS BRANCH VESSEL OCCLUSION, EVIDENCE OF STROKE AND IS CURRENTLY UNDER SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71500 VIA MICROCATHETER CONTINUOUS FLUSH CATHETER DQY SEQUENT MEDICAL INC. VIA-27-154-01 13060502

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening