BEUDAMED
    FDA Adverse Event Injury Summary report: N

    088 ACCESS SYSTEM (HIPOINT 88)

    MDR report key: 16436599 · Received February 24, 2023

    Report

    Report Number
    3016522967-2023-00001
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    January 28, 2023
    Report Date
    February 23, 2023
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K201518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH A RIGHT CAROTID STENOSIS > 95% AND A RIGHT M1 OCCLUSION. PATIENT' LEFT ICA WAS FULLY OCCLUDED. THE PHYSICIAN THEN PLACED A BASE CAMP GUIDE SHEATH PROXIMAL TO CAROTID STENOSIS. THE PATIENT WAS HEPARINIZED AND A CAROTID STENT WAS DEPLOYED. THE PHYSICIAN THEN USED TENZING 8 AND HIPOINT 88 TO CROSS THE STENT. WHILE ADVANCING TENZING 8 TO THE M1, THE TENZING 8 GOT CAUGHT ON A STRIATE. A GUIDE WIRE WAS SUBSEQUENTLY USED TO TRY TO REDIRECT THE TENZING 8 AND IT SIMILARLY GOT CAUGHT. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN WAS ABLE TO ADVANCE THE GUIDEWIRE AND TENZING 8 / HIPOINT 88 PAST THE STRIATE. A SUBSEQUENT ANGIOGRAM SHOWED A HEMORRHAGE IN THE LOCATION OF THE STRIATE VESSEL. THE PHYSICIAN USED A SCEPTER BALLOON AND ADMINISTERED PROTOMINE TO CONTROL THE HEMORRHAGE. PATIENT CONDITION AND ADDITIONAL TREATMENT IS UNKNOWN. DEVICES WERE NOT RETURNED FOR INVESTIGATION. NO INDICATIONS OF DEVICE MALFUNCTION. UNCLEAR WHETHER TENZING 8 OR GUIDEWIRE RESULTED IN THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935418 088 ACCESS SYSTEM (HIPOINT 88) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| O 088 ACCESS CATHETER (HIPOINT 88)| ARISTOTLE 14 GUIDE WIRE| BASE CAMP SHEATH SYSTEM| HEPARIN| PROTOMINE| SCEPTER BALLOON| TENZING 8 DELIVERY CATHETER