BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2

    MDR report key: 7990562 · Received October 22, 2018

    Report

    Report Number
    7990562
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 22, 2018
    Report Date
    October 9, 2018
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CEREBRAL ANGIOGRAM, TRANSARTERIAL INTRACRANIAL THROMBECTOMY OF THE LEFT MCA ARTERY, MD HAD TO ACCESS THE THROMBUS VIA THE LEFT CAROTID ARTERY. THE ASPIRATION CATH COULD NOT BE WITHDRAWN, THE MICROCATHETER & WIRE BECAME IMMOBILE. AFTER MANY TRIES, THE WIRE WAS REMOVED & APPEARED TO HAVE BEEN SHEARED WITHIN THE CATHETER. X-RAY REVEALED THAT THE ASPIRATION CATH HAD BECOME KINKED AT THE OPENING OF THE SHEATH & COULD NOT BE REMOVED. THE MICROCATHETER & REMNANT OF MICROWIRE WERE IMMOBILIZED AT THE BEND OF THE ASPIRATION CATH IN THE CAROTID ARTERY. A CAROTID CUTDOWN WAS DONE TO REMOVE THE SHEATH WITH THE DAMAGED CATHETER & WIRE REMNANT TO BE REMOVED IN ONE PIECE. THE KINKED CATH WAS DEVICE #3, THE PENUMBRA, INC CAT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831483 SYNCHRO 2 WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR M00326110 0000010603

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA