BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    MDR report key: 17822674 · Received September 27, 2023

    Report

    Report Number
    3016522967-2023-00003
    Event Type
    Death
    Date Received
    September 27, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 18, 2023
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K223530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH ICA OCCLUSION WAS TREATED WITH THE HIPOINT 88 ACCESS SYSTEM. THE TENZING 8 DELIVERY CATHETER ENTERED THE A1 VESSEL AND THE HIPOINT 88 CATHETER WAS ADVANCED TO THE SIPHON AREA OF THE ICA. THE TENZING 8 WAS REMOVED AND ASPIRATION PERFORMED FOR APPROXIMATELY 2 MINUTES. THE HIPOINT 88 WAS RETRACTED SLIGHTLY AND THEN AN ANGIOGRAPHIC CONTRAST INJECTION WAS PERFORMED. THE A1 SEGMENT WAS TORN AWAY FROM THE ICA / M1 AREA. THE PATIENT SUFFERED A HEMORRHAGE AND DIED. THERE WAS NO PRODUCT FAILURE OR DAMAGE. ADVANCEMENT AND RETRACTION OF HIPOINT 88 AND TENZING 8 WAS NORMAL AND UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096881 HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death HIPOINT 88 SYSTEM