BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    MDR report key: 18269014 · Received December 5, 2023

    Report

    Report Number
    3016522967-2023-00004
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 5, 2023
    Report Date
    November 26, 2023
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT EXHIBITED ICAD WITH A BOVINE ARCH. PHYSICAN USED ZOOM RDL WITH TENZING 8 AND AN ARISTOTLE 14 GUIDEWIRE. THE DEVICES REACHED THE MCA AND A M1 LESION WAS RUPTURED. NO ADDITIONAL DETAILS ON PATIENT CONDITION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232992 HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ARISTOTLE 14 GUIDEWIRE| HIPOINT 88 SYSTEM| ZOOM RDL