BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONETM

    MDR report key: 17710680 · Received September 8, 2023

    Report

    Report Number
    17710680
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 18, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    USE OF A HWK M ARTHRECTOMY DEVICE IN THE FEMORAL ARTERY. THE DEVICE WOULD NOT CLOSE THE CUTTER ON ITS SHAFT. THIS HAPPENED WITH 2 HWK M DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242613 HAWKONETM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN LP H1-14550 00011434044

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Male