BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 23360913 · Received October 22, 2025

    Report

    Report Number
    3014590708-2025-00023
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    August 17, 2025
    Report Date
    October 22, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K242672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. ALTHOUGH THE LOT NUMBER FOR ZOOM 71 WAS NOT PROVIDED, THE DEVICE LOT NUMBERS SHIPPED TO THE ACCOUNT 6 MONTHS PRIOR TO COMPLAINT INITIATION WERE REVIEWED. THE MANUFACTURING RECORDS REVIEWED FOR THE PRODUCT MET THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF THE CAROTID CAVERNOUS FISTULA IS UNKNOWN. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A STROKE CASE, THE PHYSICIAN ADVANCED THE ZOOM 71 THROUGH A THIRD-PARTY ACCESS CATHETER OVER THE MICROCATHETER AND MICROWIRE TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). UPON ADVANCEMENT OF ZOOM 71 OVER THE MICROCATHETER THROUGH THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA), ZOOM 71 GOT STUCK IN THE CAVERNOUS ICA RESULTING IN THE FORMATION OF A CAROTID CAVERNOUS FISTULA (C-C FISTULA). THE C-C FISTULA WAS TREATED EMERGENTLY WITH COIL EMBOLIZATION AND THE THROMBECTOMY PROCEDURE WAS COMPLETED BY DEPLOYING A STENT RETRIEVER. POST-PROCEDURALLY, THE PATIENT WAS REPORTED TO HAVE DOUBLE VISION AND RED BULGING EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243190 ZOOM REPERFUSION CATHETER ZOOM REPERFUSION CATHETER NRY IMPERATIVE CARE INC. ICRC071137

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention EMBOGUARD GUIDE CATHETER| MARKSMAN MICRO CATHETER| SYNCHRO MICROWIRE