BEUDAMED
    FDA Adverse Event Injury Summary report: N

    072 ASPIRATION SYSTEM

    MDR report key: 21284855 · Received January 31, 2025

    Report

    Report Number
    3015614180-2025-00002
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    December 31, 2023
    Report Date
    January 28, 2025
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    NRY
    UDI-DI
    00857545008097
    PMA / PMN Number
    K222786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RETROSPECTIVE FILING FOR AN EVENT THAT OCURED 5/2/2024. THE CASE WAS REPORTED BY Q'APEL MEDICAL'S CHIEF MARKETING OFFICER WHO WAS PRESENT FOR THE CASE AND REPORTED THE FINDINGS. THE INITIAL REVIEW BY Q'APEL MEDICAL'S MEDICAL PHYSICAN AND "QUALIFIED PERSON" DETERMINED THAT THE Q'APEL DEVICE DID NOT CONTRIBUTE TO THE INJURY AND THEREFORE, THE EVENT WAS NOT REPORTABLE. NEW INFORMATION WAS OBTAINED BY Q'APEL MEDICAL FROM THE OPERATOR OF THE DEVICE ON 1/15/2025 WHICH STATED: "THERE IS NO FLUORO LOOP OF THE 2ND PASS HIPPO NAVIGATING UP TO THE CLOT. THERE IS ONE OF THE FIRST PASS AND IT NAVIGATED SMOOTHLY WITH NO WIRE ISSUES. I CAN NOT IMAGINE HOW THAT AMOUNT OF EXTRAVASATION OCCURRED FROM A MICROWIRE PERFORATION. " THE NEW INFORMATION CONCLUDED THAT THE Q'APEL MEDICAL DEVICE LIKELY CONTRINUTED TO THE INJURY THAT REQUIRED MEDICAL INTERVENTION. CASE DATE:(B)(6) 2024. 78 YO [YEAR OLD] FEMALE PATIENT. STROKE CASE R M1 OCCLUSION. 3.5 SINCE LKW. NO TNK OR TPA ADMINISTERED DUE TO A FALL. WALRUS BGC USED AS GUIDE. 1 PASS WITH HIPPO CHEEATH WITH AN ARISTOTLE 18 GW. RESULT WAS TICI 0. 2ND PASS WITH HIPPO CHEETAH AND ARISTOTLE 18 GW. ON RUN POST ASPIRATION, VESSEL RUPTURE WITH CONTRAST EXTRAVASATION VITALS REMAINED STABLE FOR PATIENT AND NO LOSS OF PRESSURE. SCEPTER BALLOON PLACED AT SITE TO ARREST BLEED FOR 5 MIN. BLEEDING CONTROLLED. NO OTHER INTERVENTION TO CONTROL THIS REQUIRED. 3RD PASS - ZOOM 55. TICI 0. 4TH PASS - ZOOM 55 TICI 0. 5TH PASS - VELOCITY MC AND TIGERTRIEVER 32MM DEPLOYED FOR 2 MINS - TICI 0. 6TH PASS - ZOOM 55 - TICI 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165769 072 ASPIRATION SYSTEM CATHETER, THROMBUS RETRIEVER, NRY Q'APEL MEDICAL INC. FG 00806-02 FG231222A-01 00857545008097

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention