BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, ANGIOPLASTY, LASER, CORONARY

    MDR report key: 17689467 · Received September 6, 2023

    Report

    Report Number
    17689467
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 12, 2023
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PATIENT'S LOWER EXTREMITY ANGIOGRAM PROCEDURE, PROVIDER WAS USING LASER WIRE. AT THE HUB WHERE THE WIRE CONNECTS TO THE MACHINE, IT STARTED TO SMOKE AND SMELL OF BURNING. THERAPY WAS DISCONTINUED AND MACHINE WAS UNPLUGGED. REPRESENTATIVE FOR PRODUCT WAS HERE AND TOOK WIRE TO SEND OFF FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987201 DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORP. CVX-300

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Male