BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPTOR 071 ASPIRATION CATHETER 0.071"

    MDR report key: 22751562 · Received August 8, 2025

    Report

    Report Number
    22751562
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 1, 2025
    Manufacturer
    BALT USA LLC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH ACUTE ISCHEMIC STROKE AND LARGE VESSEL OCCLUSION. PATIENT WAS TAKEN FOR EMERGENT INTERVENTIONAL RADIOLOGY THROMBECTOMY OF LEFT MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE WHEN THE GUIDE CATHETER AND RAPTOR 71 WAS ADVANCED OVER AN ARISTOTLE COLOSSUS GUIDEWIRE AND HOLES WERE POSITIONED AT THE AREA OF OCCLUSION, THE RAPTOR 71 WAS CONNECTED TO THE SUCTION AND AFTER 1 MINUTE THROMBECTOMY WAS PERFORMED. DURING RETRIEVAL OF THE RAPTOR 71 THERE WAS FRAGMENTATION OF A SMALL TIP COIL AT THE INTERNAL CAROTID ARTERY TERMINUS. THE REMOVED DEVICE WAS INSPECTED AND THERE WERE NO OTHER COMPROMISED AREAS OF THE DEVICE. REPEAT SUBTRACTION ANGIOGRAPHY DEMONSTRATED PERSISTENT OCCLUSION OF THE SUPERIOR DIVISION OF THE LEFT MIDDLE CEREBRAL ARTERY WITH A SMALL RING, SHAPED TIP COIL AT THE INTERNAL CAROTID ARTERY TERMINUS WITHOUT ANY ASSOCIATED THROMBUS, CONTRAST EXTRAVASATION OR VESSEL OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171730 RAPTOR 071 ASPIRATION CATHETER 0.071" ASPIRATION CATHETER NRY BALT USA LLC. RAPTOR 071 F250300118

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other