BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND BACK 360 CLASSIC 2.0MM

    MDR report key: 16468434 · Received March 1, 2023

    Report

    Report Number
    MW5115378
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    February 23, 2023
    Report Date
    February 27, 2023
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD WAS USING PRODUCT DURING PROCEDURE AND WIRE BECAME ENTANGLED INSIDE OF THE PATIENT. PATIENT REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913846 DIAMOND BACK 360 CLASSIC 2.0MM CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED 447167-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention