BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    MDR report key: 18508060 · Received January 12, 2024

    Report

    Report Number
    3016522967-2024-00001
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    November 20, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 TO REACH THE M1. NO ADDITIONAL INFORMATION PROVIDED. PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834717 HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention| O BASE CAMP SHEATH SYSTEM| HIPOINT 88 SYSTEM