BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIPOINT 88

    MDR report key: 23528433 · Received November 11, 2025

    Report

    Report Number
    3016522967-2025-00005
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    October 4, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION PROVIDED ABOUT THE PRODUCT OR THE EVENT. INSUFFICIENT INFORMATION PROVIDED TO PERFORM AN INVESTIGATION.

    Description of Event or Problem · 0

    A PATIENT DEATH OCCURED AFTER A PERFORATION IN THE CAROTID TERMINUS IN A CASE WHERE HIPOINT 88 WAS USED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645193 HIPOINT 88 PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death HIPOINT 88