BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAT RX ARTERIAL THROMBECTOMY DEVICE

    MDR report key: 23255239 · Received October 9, 2025

    Report

    Report Number
    MW5177100
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 3, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL INTERVENTION: BALLOON ANGIOPLASTY WAS PERFORMED USING A 3 X 40 MM PTA BALLOON, WHICH IMPROVED THE VASCULAR CONDITION. COMPLICATION: EMBOLIC MATERIAL WAS SUBSEQUENTLY FOUND IN THE LATERAL PLANTAR PTA BRANCH OF THE FOOT. FIRST ATTEMPT: A CAT RX PENUMBRA THROMBECTOMY DEVICE WAS USED FOR PERCUTANEOUS MECHANICAL THROMBECTOMY. THE CATHETER BROKE OUTSIDE THE PATIENT AND SHEATH, ALLOWING EASY REMOVAL. SECOND ATTEMPT: A NEW CAT RX DEVICE WAS DEPLOYED. UPON REMOVAL, THIS CATHETER ALSO BROKE, WITH THE PROXIMAL END REMAINING INSIDE THE SHEATH. ESCALATION: AFTER REMOVING THE SHEATH, THE CATHETER'S PROXIMAL END WAS FOUND IN THE LEFT EXTERNAL ILIAC ARTERY. RETRIEVAL EFFORTS: A SHORT 7 FRENCH SHEATH WAS PLACED IN THE LEFT GROIN. MULTIPLE SNARE DEVICES (MICRO SNARE AND 3-LOBE SNARE) WERE USED UNSUCCESSFULLY. RESOLUTION: A PERCUTANEOUS CUTDOWN OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED TO PHYSICALLY RETRIEVE THE BROKEN CATHETER. REFERENCE REPORT MW5177101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311876 CAT RX ARTERIAL THROMBECTOMY DEVICE CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION QEX PENUMBRA, INC. F00016467

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention