BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS ELCA CORONARY LASER ARTHRECTOMY CATHETER

    MDR report key: 19330429 · Received May 15, 2024

    Report

    Report Number
    MW5154967
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 13, 2024
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CATHETER WOULD NOT CALIBRATE USING ESTABLISHED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530707 SPECTRANETICS ELCA CORONARY LASER ARTHRECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORP. 110-004 FG023H08A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown