BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELCA

    MDR report key: 20309007 · Received September 26, 2024

    Report

    Report Number
    20309007
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 8, 2024
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN ATTEMPTING TO LASER ARTERY USING ELCA LASER ARTHERECTOMY CATHETER ERROR MESSAGE OCCURRED AND DEVICE WOULD NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199566 ELCA DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORP. 110-004 FG023C21B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female