BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA 21 MICROCATHETER

    MDR report key: 8542393 · Received April 23, 2019

    Report

    Report Number
    2032493-2019-00102
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    March 25, 2019
    Report Date
    March 25, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00851566003918
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORDS INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT FOR A BASILAR ARTERY APEX ANEURYSM, A 6F NEUROMAX GUIDING SHEATH AND A SOFIA CATHETER WERE USED TOGETHER WITH THE VIA 21 MICROCATHETER. AFTER INITIAL PLACEMENT OF THE CATHETERS, THERE WAS A PAUSE IN FLUOROSCOPY AND UPON RESUMING FLUORO, DIGITAL ROAD MAPPING IMAGES DEMONSTRATED MOVEMENT OF THE VIA CATHETER. SUBSEQUENT ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WITH RESULTING SUBARACHNOID HEMORRHAGE. HEPARIN WAS REVERSED AND THE VIA 21 WAS REMOVED AND REPLACED WITH AN SL-10 MICROCATHETER, AND AN OCCLUSION BALLOON WAS POSITIONED IN THE BASILAR ARTERY TO PREVENT BLOOD FLOW TO THE ANEURYSM. EMBOLIZATION COILS WERE THEN DEPLOYED IN THE ANEURYSM AND SUBSEQUENT ANGIOGRAPHY CONFIRMED THAT BLEEDING HAD STOPPED. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED TO RELIEVE/MONITOR INTRACRANIAL PRESSURES. IT WAS REPORTED THAT PATIENT HAD NO STROKE, BUT HAD SIGNIFICANT EDEMA IN THE BRAIN. THE PATIENT WAS TAKEN TO THE ICU AND HAS BEEN KEPT HEAVILY SEDATED SINCE THE PROCEDURE TO PREVENT PATIENT MOVEMENT AND BRAIN SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334774 VIA 21 MICROCATHETER MICROCATHETER OPR SEQUENT MEDICAL, INC FGA21154-01 19021106 00851566003918

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R