BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPERFUSION CATHETERS ZOOM 71; ZOOM 55; ZOOM 45

    MDR report key: 22532854 · Received July 17, 2025

    Report

    Report Number
    MW5172867
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 14, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ENDOVASCULAR TREATMENT PROCEDURE CONDUCTED UNDER IDE PROTOCOL NO. G200273, AN AIR EMBOLISM WAS SUSPECTED TO HAVE OCCURRED DUE TO A USER ERROR OR PROCEDURAL COMPLICATION. THIS RESULTED IN AIR BEING INTRODUCED INTRAVASCULARLY INTO THE TREATED RIGHT MIDDLE CEREBRAL ARTERY (R MCA) TERRITORY. UPON ARRIVAL TO THE ICU, THE PATIENT EXHIBITED NEUROLOGICAL DETERIORATION, INCLUDING DYSARTHRIA, LEFT UPPER EXTREMITY (LUE) PLEGIA, AND LEFT-SIDED NEGLECT. NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) PERFORMED ON (B)(6) 2025 AT 17:20 SCORED 11. HEAD CT AT 22:15 REVEALED EXTRA-AXIAL BLOOD PRODUCTS ALONG THE RIGHT SYLVIAN FISSURE, PNEUMOCEPHALUS, EVOLVING RIGHT MCA TERRITORY INFARCTION, AND INCREASED CEREBRAL EDEMA CAUSING EFFACEMENT OF THE RIGHT LATERAL VENTRICLE WITH TRACE PETECHIAL HEMORRHAGE. THE RESEARCH COORDINATOR CONDUCTED A 24-HOUR NIHSS FOLLOW-UP ON (B)(6) 2025 (SCORE: 9). BY (B)(6) 2025, THE PATIENT'S CONDITION HAD STABILIZED WITH NIHSS IMPROVING TO 2. THE EVENT WAS PREVIOUSLY REPORTED TO THE CIRB (CENTRAL INSTITUTIONAL REVIEW BOARD) AND PROMPTED AN ICF (INFORMED CONSENT FORM) UPDATE. WHILE NO DEVICE MALFUNCTION WAS IDENTIFIED, THE AIR EMBOLISM OCCURRED DURING USE OF THE DEVICE AND THE EVENT RESULTED IN SERIOUS, UNANTICIPATED NEUROLOGICAL INJURY. NO SIMILAR EVENTS HAVE BEEN PREVIOUSLY REPORTED IN THIS STUDY. PATIENT CODE: 1697, 4426, 4415; 1997, 4403. DEVICE CODE: 1670. REFERENCE REPORTS: MW5172866, MW5172868.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839500 REPERFUSION CATHETERS ZOOM 71; ZOOM 55; ZOOM 45 CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC. F2434803

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| O| L