BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM)

    MDR report key: 18269049 · Received December 5, 2023

    Report

    Report Number
    3016522967-2023-00005
    Event Type
    Death
    Date Received
    December 5, 2023
    Date of Event
    November 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCING STROKE DUE TO DISTAL OCCLUSION OF M1 SEGMENT OF THE MCA. MODERATE VESSEL TORTUOSITY. PHYSICIAN ADVANCED HIPOINT 88 WITH TENZING 8 THROUGH BASE CAMP SHEATH SYSTEM TO THE MID M1 WITH SOME DIFFICULTY. M1 VESSEL WAS SHAPED LIKE A HORSESHOE. TENZING 8 WENT EASILY TO THE DISTAL OCCLUSION, BUT THE HIPOINT 88 TIP WOULD NOT ADVANCE PAST THE MID M1 SEGMENT. THE PHYSICIAN ASPIRATED FOR 2 MINUTES EVEN THOUGH THE TIP WAS NOT AT THE CLOT. A SUBSEQUENT ANGIOGRAM INDICATED A VESSEL PERFORATION IN THE PROXIMAL SEGMENT OF THE M1. VESSEL SEALED AFTER BALLOON TAMPONADE OF VESSEL. THROMBECTOMY PROCEDURE ABORTED AND PATIENT TRANSFERRED TO ICA FOR FURTHER CARE/OBSERVATION. IT WAS LATER COMMUNICATED THAT THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235508 HIPOINT 88 ACCESS SYSTEM (088 ACCESS SYSTEM) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC. 23101902

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death BASE CAMP SHEATH SYSTEM| HIPOINT 88 SYSTEM