BEUDAMED
    FDA Adverse Event Death Summary report: N

    088 ACCESS SYSTEM

    MDR report key: 15992170 · Received December 15, 2022

    Report

    Report Number
    3016522967-2022-00003
    Event Type
    Death
    Date Received
    December 15, 2022
    Date of Event
    November 26, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 088 SYSTEM WAS DELIVERED TO THE MIDDLE CEREBRAL ARTERY UNEVENTFULLY. AN ANGIOGRAM AFTER DELIVERY SHOWED EXTRAVASATION AND HEMORRHAGE. SUBSEQUENT REVIEW AFTER THE CASE SHOWED AN ANEURYSM AT THE ORIGIN OF THE PCOM WHICH RAN PARALLEL TO THE MIDDLE CEREBRAL ARTERY. THE 088 SYSTEM MAY HAVE INADVERTENTLY ADVANCED INTO THE ANEURYSM RESULTING IN A RUPTURE AND BLEEDING. THE PATIENT EXPIRED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392916 088 ACCESS SYSTEM PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death 088 ACCESS CATHETER| TENZING 8 DELIVERY CATHETER