BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-ELITE

    MDR report key: 17224183 · Received June 29, 2023

    Report

    Report Number
    17224183
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 26, 2023
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LASER PRODUCT SPECTRANETICS TURBO ELITE 0.9 MM RX LOT #: FBE22C18A, REF #: 410-154, EXP DATE: 04/07/2024, DID NOT CALIBRATE WHEN TESTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627589 TURBO-ELITE CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORP. 410-154 FBE22C18A

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Male