BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    MDR report key: 18508078 · Received January 12, 2024

    Report

    Report Number
    3016522967-2024-00002
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A DISSECTION OCCURED IN A CASE WHEN USING BASE CAMP SHEATH SYSTEM AND HIPOINT 88. NO ADDITIONAL INFORMATION PROVIDED. PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845647 HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R BASE CAMP SHEATH SYSTEM| HIPOINT 88 SYSTEM